DETERMINANTS OF DIABETIC FOOT ULCER AMONG

ADULT DIABETIC PATIENTS ATTENDING THE DIABETIC

CLINIC IN TIKUR ANBESSA SPECIALIZED HOSPITAL,
ADDIS ABABA, ETHIOPIA, 2019.

BY:
GUESH TEKLU (BSc.)

A THESIS TO BE SUBMITTED TO ADDIS ABABA

UNIVERSITY, COLLEGE OF HEALTH SCIENCES, SCHOOL
OF NURSING AND MIDWIFERY IN PARTIAL
FULFILLMENT OF THE REQUIREMENTS FOR THE
DEGREE OF MASTER OF SCIENCES IN ADULT HEALTH
NURSING.

JUNE, 2019.
 ADDIS ABABA UNIVERSITY

COLLEGE OF HEALTH SCIENCES

SCHOOL OF NURSING & MIDWIFERY

POSTGRADUATE NURSING PROGRAM

DETERMINANTS OF DIABETIC FOOT ULCER AMONG ADULT

DIABETIC PATIENTS ATTENDING THE DIABETIC CLINIC IN
TIKUR ANBESSA SPECIALIZED HOSPITAL, ADDIS ABABA,
ETHIOPIA, 2019.
BY:
GUESH TEKLU (BSc.)
MAIN-ADVISORS:
Mr. NIGUSE TADELE (MSc, ASSISTANT PROFESSOR)
Dr. GETAHUN TAREKEGN (ENDOCRINOLOGIST)
CO-ADVISOR:
Mr. YOSEF TSIGE (RN, EdAD, BSc, MSc.)

A THESIS TO BE SUBMITTED TO ADDIS ABABA UNIVERSITY,

COLLEGE OF HEALTH SCIENCES, SCHOOL OF NURSING AND
MIDWIFERY IN PARTIAL FULFILLMENT OF THE REQUIREMENTS
FOR THE DEGREE OF MASTER OF SCIENCES IN ADULT HEALTH
NURSING.

JUNE, 2019.
ADDIS ABABA, ETHIOPIA.
 APPROVAL SHEET

I, the undersigned MSc student, declare that I have submitted my original work on a title
―Determinants of Diabetic Foot Ulcer Among Adult Diabetic Patients Attending the Diabetic
Clinic in Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2019‖, done under the
guidance of my advisors and has not been submitted for a degree in any other
university. All sources materials used for the thesis have been duly acknowledged.

Submitted by:
Name of student: Guesh Teklu (BSc.)
Signature: ______________
Date: ________________

This thesis work has been submitted for examination with our approval as an advisor.
Approved by:
Name of Main Advisor: Mr. Niguse Tadele (MSc, Assistant Professor)
Signature: ____________
Date: _______________
Name of Main Advisor: Dr. Getahun Tarekegn (Endocrinologist)
Signature: ____________
Date: _______________

Name of Co-Advisor: Mr. Yosef Tsige (RN, EdAD, BSc, MSc.)

Signature: ______________
Date: ________________

i
 APPROVAL BY THE BOARD OF EXAMINATION

This thesis by Guesh Teklu is accepted in its present form by the board of examiners as
satisfying thesis requirement for the degree of masters in Adult Health Nursing.

Examiner:
Name: Mr. Girum Sebsibie (MSc, Assistant Professor)
Signature: ____________
Date: _______________

Research Advisors:
Name of Main Advisor: Mr. Niguse Tadele (MSc, Assistant Professor)
Signature: ____________
Date: _______________
Name of Main Advisor: Dr. Getahun Tarekegn (Endocrinologist)
Signature: ____________
Date: _______________

Name of Co-Advisor: Mr. Yosef Tsige (RN, EdAD, BSc, MSc.)

Signature: ______________
Date: ________________

Department Head:
Mr. Birhanu Wordofa (MSc, Assistant Professor)
Signature: ______________
Date: ________________

ii
 ACKNOWLEDGEMENTS

My gratitude goes to Addis Ababa University, College of Health Sciences, School of

Nursing and Midwifery for providing me a chance to attend this post graduate study as
well for sponsoring me to do this thesis, and to Adigrat University, who sponsored me to
pursue my post graduate study.

I would like to express my deepest appreciation and sincere gratitude to my advisors, Mr.
Niguse Tadele (MSc, Assistant Professor), Mr. Yosief Tsige (RN, EdAD, BSc, MSc), and
Dr. Getahun Tarekegn (Consultant Internist, Endocrinologist) for their unreserved advice
and encouragement, provision of relevant and timely comments and guidance of the
overall process from proposal development to the end of this thesis, without their
contribution and advice, I would have never been able to progress with the work in the
thesis.

I would also like to extend my gratitude to the Addis Ababa University, College of Health
Sciences, main library staffs for their cooperation during accessing of internet which was
helpful for searching relevant literatures and reports.

My special thanks also go to all staffs of the School of Nursing and Midwifery and to my
classmates, for all the encouragements and support that they have provided me and for all
the nice moments I had during my study years.

I am very grateful to Mr. Alem Gebremariam (Assistant Professor, PhD Candidate), for
his invaluable comments and suggestions, which contributed to the successful realization
of the study.

I would also like to thank the study participants who were participants of this research,
data supervisor and data collectors, without their passionate participation and input, the
study could not have been successfully conducted.

iii
 TABLE OF CONTENTS

APPROVAL SHEET i
APPROVAL BY THE BOARD OF EXAMINATION ii
ACKNOWLEDGEMENTS iii
TABLE OF CONTENTS iv
ABBREVIATIONS AND ACRONYMS vii
LIST OF FIGURES viii
LIST OF TABLES ix
ABSTRACT x
1. INTRODUCTION 1
1.1. Background 1
1.2. Statement of the problem 3
1.3. Significance of the study 5
2. LITERATURE REVIEW 6
2.1. Introduction 6
2.2. Socio-demographic factors of diabetic foot ulcer 6
2.3. Clinical factors of diabetic foot ulcer 7
2.4. Behavioral factors of diabetic foot ulcer 9
2.5. Biological factors of diabetic foot ulcer 10
2.6. Conceptual framework for determinants of diabetic foot ulcer 11
3. OBJECTIVES 12
3.1. General objective 12
3.2. Specific objectives 12
4. METHODS AND MATERIALS 13
4.1. Study area and period 13
4.2. Study design 13
4.3. Population 13
4.3.1. Source population 13
4.3.2. Study population 14
4.4. Eligibility criteria 14
4.4.1. Inclusion criteria 14
4.4.2. Exclusion criteria 14

iv
 4.5. Sample size determination 14
4.6. Sampling technique and procedures 15
4.7. Data collection tools and procedures 16
4.8. Study variables 16
4.8.1. Dependent variable 16
4.8.2. Independent variables 17
4.9. Operational definitions 17
4.10. Data quality assurance 19
4.11. Data analysis procedures 19
4.12. Ethical consideration 20
4.13. Dissemination of the result 20
5. RESULTS 21
5.1. Socio-demographic characteristics of respondents 21
5.2. Clinical characteristics of respondents 23
5.3. Behavioral factors of respondents 25
5.4. Biological factors of the study participants 27
5.5. Factors associated with diabetic foot ulcer 28
5.5.1. Bivariate analysis of factors affecting diabetic foot ulcer 28
[Link]. Bivariate analysis of socio-demographic characteristics 28
[Link]. Bivariate analysis of clinical factors 29
[Link]. Bivariate analysis of behavioral factors 30
5.5.2. Multivariable analysis of factors affecting diabetic foot ulcer 32
6. DISCUSSIONS 34
7. STRENGTHS AND LIMITATIONS OF THE STUDY 37
7.1. Strength of the study 37
7.2. Limitations of the study 37
8. CONCLUSIONS AND RECOMMENDATIONS 38
8.1. Conclusions 38
8.2. Recommendations 38
9. REFERENCES 39
10. APPENDIXES 48
10.1. Appendix I: Information sheet (English version) 48
10.2. Appendix II: Consent form (English version) 50

v
10.3. Appendix III: Questionnaire (English version) 51
10.4. Appendix IV: Information sheet (Amharic Version) 55
10.5. Appendix V: Consent form (Amharic Version) 57
10.6. Appendix VI: Questionnaire (Amharic Version) 58

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 ABBREVIATIONS AND ACRONYMS

AOR: Adjusted Odds Ratio

BMI: Body Mass Index
BP: Blood Pressure
CI: Confidence Interval
DBP: Diastolic Blood Pressure
DFU: Diabetic Foot Ulcer
DM: Diabetes Mellitus
FBS: Fasting Blood Sugar
HDL: High Density Lipoprotein
Hgb A1C: Glycosated Hemoglobin
HMIS: Health Management Information System
LDL: Low Density Lipoprotein
OR: Odds Ratio
RBS: Random Blood Sugar
SBP: Systolic Blood Pressure
SD: Standard Deviation
SPSS: Statistical Package for Social Sciences
TASH: Tikur Anbessa Specialized Hospital

vii
 LIST OF FIGURES

Figure 1: Conceptual framework for determinants of diabetic foot ulcer among diabetic
patients in TASH, Addis Ababa, Ethiopia, 2019. 11
Figure 2: Schematic presentation of the sampling procedure for study participants in TASH,
Addis Ababa, Ethiopia, 2019. 15
Figure 3: Skin problems of the study participants attending the diabetic clinic in TASH, Addis
Ababa, Ethiopia, 2019, (n=161). 24
Figure 4: BP status of the study participants attending the diabetic clinic in TASH, Addis
Ababa, Ethiopia, 2019, (n=161). 24

viii
 LIST OF TABLES

Table 1: Socio demographic characteristics of the study participants attending the diabetic
clinic in TASH, Addis Ababa, Ethiopia, 2019, (n=161). 22
Table 2: Clinical factors of the study participants attending the diabetic clinic in TASH, Addis
Ababa, Ethiopia, 2019, (n=161). 23
Table 3: Behavioral factors of the study participants attending the diabetic clinic in TASH,
Addis Ababa, Ethiopia, 2019, (n=161). 26
Table 4: Biological factors of the study participants attending the diabetic clinic in TASH,
Addis Ababa, Ethiopia, 2019, (n=161). 27
Table 5: Bivariate analysis of the socio-demographic characteristics of study participants
attending the diabetic clinic in TASH, Addis Ababa, Ethiopia, 2019, (n=161). 28
Table 6: Bivariate analysis of the clinical factors of study participants attending the diabetic
clinic in TASH, Addis Ababa, Ethiopia, 2019, (n=161). 29
Table 7: Bivariate analysis of the behavioral factors of study participants attending the
diabetic clinic in TASH, Addis Ababa, Ethiopia, 2019, (n=161). 30
Table 8: Bivariate and multivariable logistic regression for determinants of diabetic foot ulcer
among diabetic patients attending the diabetic clinic in TASH, Addis Ababa, Ethiopia, 2019,
(n=161). 33

ix
 ABSTRACT

Background: Diabetic foot ulcer is among the commonest complications of diabetic mellitus
attributing to a significant number of morbidity and mortality in diabetic patients, and
enormous economic loss to the families and the country. Nowadays, the incidence of diabetic
foot ulcer is increasing due to the increased prevalence of diabetes, prolonged life expectancy of
diabetic patients and lifestyle change. However, the risk factor of the problem is less studied in
Ethiopia.
Objective: To assess determinants of diabetic foot ulcer among diabetic patients attending
diabetic clinic in Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2019.
Methods: An institution based unmatched case-control study was conducted on 161 diabetic
patients. Cases were selected from diabetic patients with foot ulcer by consecutive sampling
technique and controls from diabetic patients without diabetic foot ulcer by systematic
random sampling technique. Binary logistic regression model was used to assess the
association between the dependent and independent variables. All variables with P-value <
0.25 were included in the multivariable analysis. The magnitude of the association was
measured by using an Odds Ratio with its 95% confidence interval. Statistical significance
was declared at P- value < 0.05.
Results: In this study, among the 53 diabetic patients with foot ulcer and 108 diabetic patients
without foot ulcer, 28 (33.7%) in cases and 55 (66.3%) in controls were males. Taking insulin
alone [AOR: 2.75, 95% CI: 1.04-7.23], having peripheral neuropathy [AOR: 7.56, 95% CI:
2.82-20.24], not inspecting feet daily [AOR: 5.61, 95% CI: 2.24-14.05], and using
moisturizing cream between toes [AOR: 3.35, 95% CI: 1.35-8.32], were positively associated
with diabetic foot ulcer. Whereas, employed [AOR: 0.35, 95%CI: 0.14-0.87], and combined
treatment (insulin and oral hypoglycemic agents) [AOR: 0.11, 95%CI: 0.02-0.57] were
negatively associated with diabetic foot ulcer.
Conclusion and Recommendations: Diabetic foot ulcer was significantly associated with
occupation, kind of treatment of diabetes mellitus taking, peripheral neuropathy, inspecting
feet daily and putting moisturizing cream between toes. It will be helpful if diabetic patients
inspect their feet on daily bases and do not put moisturizing cream between their toes.

Key words: Diabetic Foot Ulcer, Determinants, Addis Ababa

x
 1. INTRODUCTION

1.1. Background

Diabetes mellitus (DM) is a group of metabolic disorders that is characterized by increased

levels of glucose in the blood (hyperglycemia) that results from defects in insulin secretion,
insulin action, or both (1).

The incidence of diabetes mellitus is increasing worldwide. The number of people with diabetes
aged from 20-79 years was 424.9 million in 2017, and it is estimated that by 2045, it will grow up
to 628.6 million due to the change in life expectancy, lifestyle, and diet of the people (2). In the
United States, an estimated 1.5 million new cases of diabetes (6.7 per 1,000 persons) were diagnosed
among adults aged 18 years or older in the year 2015 (3).

Diabetes mellitus causes macro-vascular and micro-vascular complications. Diabetic foot

ulcer (DFU) is among the long-term and micro vascular complications of diabetic mellitus
that have life time risk up to 25%, though many of the occurrences could be prevented (1, 4).

Diabetic foot ulcer is among the overwhelming complications of diabetic mellitus and causes
diabetes related foot deformities that play a great role in the development of further diabetic
foot ulcers (5).
People who are at greatest risk of diabetic foot ulceration can easily be identified by careful
physical examination of the feet while giving the routine care on their follow ups. Foot
problems in diabetic patients account for more hospital admissions than any other long-term
complications of diabetes mellitus. Foot problems also resulted in increasing diseases and
death among diabetic patients (6).

Diabetic foot ulcer causes minor and major lower extremity amputations and death among
diabetic patients (7). So that people with diabetes who has peripheral neuropathy should be
screened for a history of foot ulceration or lower-extremity amputation, peripheral artery
disease, foot deformity, pre-ulcerative signs on the foot, poor foot hygiene and ill-fitting or
inadequate footwear in order to prevent these devastating complications (8).

Though diabetic foot ulcer can be prevented by a multidisciplinary health professional’s

approach, it is important to teach and instruct diabetic patients to protect their feet by wearing

1
properly fitting footwear, not to walk barefoot or in socks only, whether at home or when
outside. They should also be taught and instructed to inspect their feet and the inner side of
their shoes, wash their feet (with careful drying particularly between the toes) on daily basis,
use emollients to lubricate dry skin for a better outcome (8).
The risk of diabetic foot ulcers or amputations are high in people who have previous
amputations, history of past foot ulcer, peripheral neuropathy, foot deformity, visual
impairment, poor glycemic control and cigarette smoking (9). Therefore diabetic patients with
either of these problems should attain special care to minimize the possible complications.

2
1.2. Statement of the problem

A diabetic foot ulcer is a non-traumatic lesion of the skin (partial or full thickness) on the foot
of a person who has diabetes mellitus (4).

The global prevalence of diabetic foot ulcer was 6.3%, which was higher in males and in type
2 diabetic patients. The prevalence of diabetic foot ulcer in Africa was 7.2% (10). The
prevalence of diabetic foot ulcer was 18.1% among patients with type two diabetes mellitus
who are on treatment in Khartoum, Sudan (11). According to the studies conducted in
different regions of Ethiopia, the prevalence of diabetic foot ulcer was: 14.8%, 13.6%, 12%,
and 4.4% in Arbamich, Gondar, Mekelle, and Dessie respectively (4,12–14)

Diabetic foot ulcer is the major cause of lower extremity amputations in diabetic patients.
Every 30 seconds a lower limb or part of a lower limb is lost to amputation somewhere in the
world as a consequence of diabetes (2). The study conducted in Turkey revealed that 41.4%
of diabetic patients with diabetic foot ulcer underwent an amputation (15). Moreover, diabetic
foot ulcer accelerates mortality rate among diabetic patients as shown by the retrospective
cohort study conducted in Saudi Arabia stating deceased patients increased by almost twofold
in diabetic patients with foot ulcers compared to diabetic patients without foot ulcers (16).
Similarly, a study from the United Kingdom also revealed higher rate of mortality among DM
patients with DFU compared to those without DFU. Among the diabetic patients who
developed new onset foot ulcer, 8.1% died within 12 months of their diabetic foot ulcer
follow up, and the 5–year death rate for people with diabetic foot ulcer was 42.2% (17).
Diabetic foot ulcer compromises the quality of life as indicated by the study conducted in
India on the impact of diabetic foot ulceration on Health-Related Quality of Life, in which
patients with diabetic foot ulcer were having low scores of health-related quality (18).

The economic burden of diabetic foot ulcer should not be undermined as it requires much
expense for treatment purpose. The study conducted in Canada shows that the annual average
resource utilization associated with diabetic foot ulcer for acute institutional care was $358.6
million (19).
The study done in Singapore among diabetic patients with diabetic foot problems shows 28%
had minor surgery, 22.9% had minor amputations, and 23.8% had major amputations. Their

3
annual average costs for the surgeries were $486.07, $397.57 and $1192.74 respectively (20).
So it can be imagined that diabetic foot ulcer not only affects the quality of life of an
individual but also has great burden in economic aspect of individuals.

According to the study done in Tikur Anbessa Specialized Hospital, nearly one-third of the
diabetic patients were admitted with the problem of diabetic foot ulcer which implies that
diabetic foot ulcer has higher admission rates compared with the other complications of DM
(21).

Several factors have contributed to the development of diabetic foot ulcer. Which includes
foot deformity, prior amputation, trauma, peripheral arterial disease, peripheral neuropathy,
hypertension, duration of diabetes mellitus for greater than ten years, male gender, age greater
than 45 years old, Non-noticeable repetitive trauma, longer duration of past foot ulcers were
significant factors for the development of diabetic foot ulcer (22–24).

Patients who received integrated foot care, health education regarding diabetic foot,
therapeutic footwear and Custom-Made Footwear were showing less percentage of diabetic
foot ulcers and their foot care behaviors were improved after health education (25–27).

Patients with diabetic foot infections require some form of podiatric care in addition to the
medical, surgical or nursing care they receive. Podiatric care is particularly aimed at
preventing foot complications which includes debridement of callus and necrotic tissue, nail
care (especially with Onychomycosis) (28).

Several studies have attempted to identify risk factors for diabetic foot ulcer, but did not
assess the status of putting moisturizing cream between toes, family support during foot care
and physical activity (exercise) status of the individual as possible risk factors for the
development of diabetic foot ulcer. Therefore this study was intended to incorporate the status
of putting moisturizing cream between toes, family support during foot care and physical
activity status of the individual in the questionnaire which play a role for the development of
DFU in diabetic patients.

4
1.3. Significance of the study

The number of people with diabetes mellitus is increasing due to lifestyle change and living
condition, overweight, obesity and hypertension, and the numbers of lower extremity
amputations are more among diabetic patients (29,30)

The incidence of diabetic foot is increasing due to the increased prevalence of diabetes and
the prolonged life expectancy of diabetic patients. Amputation in people with diabetes is 10 to
20 times more common compared to those of non-diabetic people (2). Hence studying risk
factors of diabetic foot ulcer is essential for minimizing the morbidities and complications
taking place secondary to DM.

This study assessed the status of putting moisturizing cream between toes, family support
during foot care and physical activity (exercise) status of the individual which play a role for
the development of DFU in diabetic patients that are not studied in other studies as possible
risk factors for DFU. This study was also conducted in a previously unstudied area.

Diabetic foot ulcer can be prevented if the risk factors are identified and appropriate measures
are implemented to maintain skin integrity. Once it occurs, it may extend from pain and
suffering to end of life.

This study assessed determinants of diabetic foot ulcer among diabetic patients which can
help nurses in planning nursing care for diabetic patients and diabetic patients will be
benefitted from the interventions provided by nurses and can be an input for researchers,
community planners, and policymakers for their future interventions and activities.

In addition, this research is expected to produce a crucial output since there are no studies
conducted on determinants of diabetic foot ulcer in Tikur Anbessa Specialized Hospital

5
 2. LITERATURE REVIEW

2.1. Introduction

Nowadays, the number of people with DM is increasing due to aging, lifestyle change,
obesity, and physical inactivity. Foot ulceration is one of the common complications of DM
that is associated with an increased risk of death (17). The retrospective study done in the
Johns Hopkins Hospital, Baltimore, United States of America showed that the general ratio of
foot ulcer admissions was considerably higher in patients with diabetes than those without
diabetes (11.2, 95% CI 10.8–11.5; P < 0.001) (31). Hence studying risk factors of DFU is
essential for minimizing the morbidities and mortalities occurring secondary to DFU.

2.2. Socio-demographic factors of diabetic foot ulcer

The case-control study conducted in Poland states that DFU was high among male diabetic
patients (OR = 2.83, 95% CI: 1.86-4.28, p = 0.00001) (32), this finding is similar to the
cross-sectional study conducted in Saudi Arabia that states, male gender was a significant
risk factor for the development of DFU (23), but it is inconsistent with the cross-sectional
study done in Australia that states, female gender OR 1.52 (1.08-2.14) was a significant risk
factor that contributes to the development of DFU (33).

The systematic review and meta-analysis study done in China showed that patients with DFU
were older (10), this finding is similar to the cross-sectional study done in Iraq that shows,
older age was significantly associated with the development of DFU (34).

The case-control study done in Malaysia among diabetic patients with foot ulcer and without
foot ulcer states, patients in the age group of < 60 years were five times more likely to
develop DFU [OR 4.5] (35), which is inconsistent to the cross-sectional study conducted in
Saudi Arabia that states age > 45 years were significant risk factors for the development of
DFU (23).

According to the cross-sectional study done in Arbamich Hospital, Ethiopia, diabetic patients
who live in rural areas were 4.074 times more to develop DFU than those living in urban
(AOR 4.07, 95% CI 1.262-13.151). Diabetic patients who were farmers were 6.54 times more
to develop DFU than other employees (AOR 6.542, 95% CI 2.841-49.035) (4).

6
2.3. Clinical factors of diabetic foot ulcer

According to the comparative cross-sectional study done in Brazil, the proportion of men
were having poorer glycemic control compared to women (HgbA1C 9.23 ± 2.03 vs. 8.35 ±
1.99; p < 0.001) (36).

A retrospective study done in two Maltese Health Centre catchment areas, Malta showed
71.2% of the diabetic patients were having hypertension. Besides 49.4% and 39% of the
patients were having hallux valgus and hammer toes foot deformities (37).

The systematic review and meta-analysis study done in China showed that patients with
diabetic foot ulcer were having longer diabetic duration, more hypertensive than diabetic
patients without a diabetic foot (10).

The case-control study done in Malaysia states that HgbA1C level > 6.5% was a significant
determinant of DFU (35), this finding is similar to the cross-sectional study conducted in
Saudi Arabia that states, poor glycemic control was a significant risk factors for the
development of DFUs (23).

According to the cross-sectional study done in Australia, some of the significant risk factors
contributing to the development of DFU were peripheral neuropathy OR 1.77 (1.09-2.86)
(33), this finding in lines with the prospective cohort study done in Iran that reveals, distal
neuropathy OR = 3.37 (1.40–8.09), P = 0.007] was having statistically significant
relationship with the incidence of DFU (38).

According to the study in Eastern Indonesia; deformity was significant in the control group
and dry skin was significantly associated in the case group for the development of DFUs (39),
which is similar to the prospective cohort study done in Iran that reveals foot deformity OR =
3.02 (1.10–8.29), P = 0.032] was having statistically significant relationship with the
incidence of DFU (38), this finding is also similar to the cross-sectional study done in
Australia, that states, patients with foot deformity were 1.44 times more likely OR 1.44 (1.02-
2.04) to develop DFUs (33).

The prospective cohort study done in Iran reveals that, insulin usage OR = 5.78 (2.37–14.07),
P < 0.01] was having a statistically significant relationship with the incidence of DFU (38),

7
this finding is inconsistent with the cross-sectional study conducted in Saudi Arabia that
states, insulin use was no significant risk factor for the development of DFU (23), and with
the cross-sectional study done in Iraq showed that using a combination of insulin and oral
antidiabetic agents were significantly associated with the development of DFUs (34), but the
case-control study done in Malaysia that showed both insulin and oral hypoglycemic agents
were not significantly associated with DFU (35), and with a cross-sectional study conducted
in University of Gondar Referral Hospital, Ethiopia, that showed taking insulin was not
significantly associated with DFU (12).

The comparative cross-sectional study done in Iraq showed that, long history of DM (greater
than 10 years), was significantly associated with the development of DFU (34), this is similar
to the case-control study done in Malaysia that states, patients with chronic DM lasting more
than ten years were seven times more likely to develop foot ulcers [OR 6.7] (35), which is
also similar to the cross-sectional study conducted in Saudi Arabia that states, duration of
diabetes mellitus > 10 years were significant risk factors for the development of diabetic foot
ulcer (23), and also similar to the cross-sectional study done in Arbamich Hospital, Ethiopia,
that states diabetic patients with DM for greater than 10 years were 8.452 times more to
develop DFU than those with less than 10 years (AOR, 8.452, 95% CI 2.305, 30.994) (4).

According to the comparative cross-sectional study done in Lahore General Hospital,

Pakistan, co-morbid conditions were significantly associated with the development of DFUs
among patients with DFUs (40), this finding is inconsistent with the cross-sectional study
done in Iraq that showed the presence of comorbid diseases was not significantly associated
with the development of DFUs (34).

The cross-sectional study conducted in Saudi Arabia states that peripheral vascular disease
(PVD), coronary artery disease (CAD), and hypertension were significant risk factors for the
development of diabetic foot ulcers (23).

The Retrospective study conducted in Nigeria in One hundred and seven diabetic patients
with foot ulcer/gangrene reveals that Tinea pedis (fungal infection) 5.1% was the identified
risk factors for DFU among the patients (41).

8
The cross-sectional study conducted at the University of Gondar Referral Hospital, Ethiopia,
reveals that diabetic patients with type II DM were 2.58 times more to develop DFU than
those with type I DM (AOR = 2.58; 95% CI: 1.22, 6.45) (12), which is similar with the cross-
sectional study conducted in Saudi Arabia that states, DFU more occurred in type II diabetic
patients (23).

According to the comparative cross-sectional study done in Lahore General Hospital,

Pakistan, obesity was significantly associated with the development of DFUs among patients
with DFUs (40), which is similar to the retrospective, cross-sectional study done in Selebi
Phikwe Government Hospital, Botswana that shows, more than half of the patients had a
BMI above the median value (28 kg/m2) (42), which also has similar finding with the cross-
sectional study conducted in the University of Gondar Referral Hospital, Ethiopia, that reveals
diabetic patients who were overweight were 2.12 times more to develop DFU than those of
normal weight (AOR= 2.12; 95% CI: 1.15, 3.10). Obese diabetic patients were 2.65 times
more to develop DFUs than those with normal body mass index (AOR = 2.65; 95% CI: 1.25,
5.83) (12). But inconsistent with the systematic review and meta-analysis study done in China
that showed patients with DFU were, having a lower body mass index compared to diabetic
patients without a DFU (10).

2.4. Behavioral factors of diabetic foot ulcer

The retrospective study done in two Maltese Health Centre catchment areas, Malta showed
that 56% of the diabetic patients wear unsuitable footwear, and 54% of the patients never had
any prior foot care education (37), this finding is similar to the retrospective study conducted
in Nigeria in One hundred and seven diabetic patients with foot ulcer/gangrene that reveals
ill-fitting footwear 6.2% was the identified risk factors for DFU among the patients (41).

The systematic review and meta-analysis study done in China showed that patients with DFU
were having a higher percentage of smoking than diabetic patients without a DFU (10),
which in lines with the cross-sectional study conducted in Saudi Arabia states that smoking
was significant risk factors for the development of diabetic foot ulcers (23).

9
According to the study in Eastern Indonesia; daily foot inspection, entirely foot inspection and
supported for foot inspection by family members were significant in the control group for the
development of DFUs (39).

The comparative cross-sectional study done in Iraq showed that physical activity was
significantly associated with the development of DFUs (34).

2.5. Biological factors of diabetic foot ulcer

The case-control study conducted in Poland states that hyperlipidemia OR = 0.54, 95% CI:
0.36-0.81, p = 0.01 was a factor that helps to protect DFUs in type II diabetic patients (32).

The case-control study conducted in the United Arab Emirates reveals that the mean values of
lipid profiles i.e. HDL was high and statistically significant among cases compared to
controls. But the mean value of postprandial blood glucose was significantly higher for
diabetic patients without foot ulcers (43).

10
2.6. Conceptual framework for determinants of diabetic foot ulcer

This conceptual framework describes factors that are related to the development of diabetic
foot ulcer among diabetic patients. These factors includes: Socio-demographic factors like
age, sex, occupation; Clinical factors like type of DM, duration of DM, history of foot ulcer,
history of amputation; Behavioral factors like walking barefoot, appropriate wear, inspecting,
washing feet daily smoking, alcohol intake, and Biological factors like cholesterol. As
identified by reviewing different studies, these factors have an association with diabetic foot
ulcer (4,12,13,23,33–36,38–44).

Socio-demographic factors:
Age, sex, marital status, level
of education, occupation, area
of residence
Clinical factors:
Type of DM,
Duration with DM, Biological factors:
follow ups, Cholesterol,
Treatment type, Triglyceride,
Skin, nail problems, Diabetic Foot Ulcer LDL,
Foot deformity, HDL
Comorbidity
BP, BMI, RBS/FBS,
Hgb A1C

Behavioral factors:
Walking barefoot, appropriate wear,
inspecting, washing feet daily,
inspecting shoes for foreign objects,
Using moisturizer after washing,
Attending class on DFUs, reading
manuals on foot care and proper foot
wear, exercise, family support during
foot care, smoking, alcohol intake

Figure 1: Conceptual framework for determinants of diabetic foot ulcer among diabetic
patients in TASH, Addis Ababa, Ethiopia, 2019.

11
 3. OBJECTIVES

3.1. General objective

 To assess determinants of diabetic foot ulcer among diabetic patients attending the
diabetic clinic in Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2019.

3.2. Specific objectives

 To describe the socio-demographic characteristics associated with diabetic patients

attending the diabetic clinic in Tikur Anbessa Specialized Hospital, Addis Ababa,
Ethiopia, 2019.
 To identify the clinical factors associated with diabetic patients attending the diabetic
clinic in Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2019.
 To identify the behavioral factors associated with diabetic patients attending the
diabetic clinic in Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2019.
 To determine the biological factors associated with diabetic patients attending the
diabetic clinic in Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2019.

12
 4. METHODS AND MATERIALS
4.1. Study area and period

The study was conducted in Tikur Anbessa Specialized Hospital (TASH), Addis Ababa,
Ethiopia, from March 27 – May 13 /2019. According to data from the hospital’s
administrative unit; the hospital was inaugurated in 1972. TASH is a specialized referral
teaching hospital which is managed by Addis Ababa University. The hospital provides multi-
dimensional aspects of care to clients who need health care service including pediatrics,
medical, surgical, gynecological and other services. The hospital also has special units
(referral clinics); those are Chest, Renal, Neurology, Cardiology, Dermatology and Sexually
Transmitted Diseases, Gastrointestinal, Infectious Diseases, Orthopedics, General Surgical,
Gynecologic and Obstetrics, Diabetic, Hematology, and Medical Intensive Care Unit. This
hospital sees approximately 370,000 – 400,000 patients a year. It has 625 beds with 130
specialists, 50 non-teaching doctors, and 836 nurses.

The diabetic center of TASH is a separate unit which was inaugurated in 1994 by Professor
Dr. Giuseppe PINO Grimaldi, president of the International Association of Lions Clubs. The
report from Health Management Information System (HMIS) shows, the diabetic center
provides an outpatient and inpatient service for around 11000 diabetic patients annually.

4.2. Study design

Institution based unmatched case-control study design was employed.

4.3. Population

4.3.1. Source population

The source populations for this study were all adult diabetic patients attending the diabetic
clinic in TASH.

13
4.3.2. Study population

[Link]. Cases

Adult diabetic patients who developed diabetic foot ulcer that was diagnosed by a physician
and attending the diabetic clinic in TASH during the study period.

[Link]. Controls

Adult diabetic patients who did not develop diabetic foot ulcer and attending the diabetic
clinic in TASH during the study period.

4.4. Eligibility criteria

4.4.1. Inclusion criteria

Cases: All adult DM patients who developed DFU and attending the diabetic clinic in TASH
were included.
Controls: All adult DM patients who did not develop DFU and attending the diabetic clinic in
TASH were included.

4.4.2. Exclusion criteria

Diabetic patients who had traumatic ulcer due to car accident or any injury and those who are
severely ill and unable to communicate and patients with incomplete laboratory records were
excluded.

4.5. Sample size determination

Sample size was determined by using Epi Info Version 7 statistical software to determine two
population proportion by using 95% CI, power 80%, control to case ratio 2, OR = 3 which is
the ratio of odds of dry skin among diabetic patients with diabetic foot ulcer to odds of dry
skin among diabetic patients without diabetic foot ulcer, probability of exposure to dry skin
among diabetic patients without diabetic foot ulcer =19.6% and probability of exposure to dry
skin among diabetic patients with diabetic foot ulcer as 43.3% (39).

14
The calculated sample size was 147 (49 cases and 98 controls). By adding 10% non-response
rate, the total sample size was 162 (54 cases and 108 controls).

4.6. Sampling technique and procedures

Diabetic patients with a foot ulcer and without foot ulcer were taken from the HMIS database
and from the diabetic clinic registry book.

Since diabetic patients without foot ulcer and with foot ulcer were appointed in different day,
they were selected differently as follows.

Controls were selected from diabetic patients without diabetic foot ulcer using systematic
random sampling technique with every 9th interval (K=N/n) until the predetermined sample
size was obtained. The first control was selected using lottery method, and it was the 5th
participant. Cases were selected from diabetic patients with foot ulcer using consecutive
sampling technique until the predetermined sample size was obtained.
The annual number of diabetic patients without foot ulcer and with foot ulcer that were seen by the
diabetic clinic were 8000 and 252 respectively.

TASH

Diabetic clinic

Controls = Cases =
8000 252

108 controls: 54 cases

Figure 2: Schematic presentation of the sampling procedure for study participants in TASH,
Addis Ababa, Ethiopia, 2019.

15
4.7. Data collection tools and procedures

The questionnaire was developed by the principal investigator by selecting and modifying
different similar articles (4,12,13,39,40,42) and standard evaluation tools (44–47) for diabetic
foot ulcers and all the variables of interest were assessed accordingly.

An interviewer-administered structured questionnaire and record review were used to collect

data from the cases and controls. The questionnaire comprises four parts.

The first part is: Socio-demographic characteristics of respondents like age, sex, marital
status, which has 6 items.
The second part is: Clinical factors related questions of respondents like type of DM, duration
of DM, history of DFU, history of amputation, which has 15 items.
The third part is: Behavioral factors related questions like walking bare foot, inspecting and
washing feet daily, which has 21 items.
The fifth part is: Biologic factors of the respondents (laboratory results) of the respondents
like FBS, HgbA1C, LDL, HDL, which will be taken from patient card. It has 4 items.

Weight, height and blood pressure of the study participants was measured as follows.
Weight was measured in light closing and without shoes in kilograms (kg).

Height was measured using stadiometer in centimeter (cm) in erect position that the back of
the head, shoulder blades, buttocks, and heels make contact with the backboard with shoes
removed.
Blood pressure was measured using a mercury sphygmomanometer with a cuff deflation rate
of 2 mmHg.

4.8. Study variables

4.8.1. Dependent variable

 Diabetic foot ulcer

16
4.8.2. Independent variables

Socio-demographic factors:
 Age, sex, marital status, level of education, occupation, area of residence

Clinical factors:
 Type of DM, duration with DM,
 Follow up, treatment type,
 Skin, nail problems, foot deformity,
 Comorbidity (hypertension, heart disease, peripheral neuropathy)
 BP, BMI, FBS
 Hgb A1C
Behavioral factors:
 Walking barefoot, appropriate foot wear,
 Inspecting, washing feet daily, inspecting shoes for foreign objects,
 Using moisturizer after washing,
 Attending class on diabetic foot ulcers, reading manuals on foot care and proper foot
wear,
 Exercise, smoking, alcohol intake
Biological factors:
 Cholesterol, Triglyceride,
 LDL, HDL

4.9. Operational definitions

Case (Patient with diabetic foot ulcer): was a diabetic patient who was diagnosed as having
foot ulcer which was identified from patient card.

Control (Patient without diabetic foot ulcer): was a diabetic patient who was not diagnosed as
having foot ulcer which was identified from patient card.

Foot deformity: when the big toe of the diabetic patients was turned toward the second toe
and the base of big toe was pushed to the side, and if the tip of the toe was bent.

17
Well fit foot wear: A footwear that was wider than the size of the foot. That was checked by
measuring the size of foot on a paper with a marker and that of a shoe. Then both the size of
the foot and shoe were compared, and no reddened areas on the foot on removal of the
footwear.

Ill fit foot wear: when footwear was equal to the size of the foot and there were reddened
areas on the foot on removal of the footwear.

Callus: diabetic patients were observed and palpated for the presence of thick areas on the
bottom or sides of feet and toes.

Dry skin: diabetic patients were observed and palpated for a rough skin.

Tinea pedis: diabetic patients were observed for erythema and fissuring between the toes due
to fungal infection.

Nail deformity: diabetic patients were observed for ingrown toenail or thickened nail fold
skin.

Onychomycosis: nail of diabetic patients were observed for foul smelling, dark color, brittle
and thickened nails.

Peripheral neuropathy: loss of sensation. The 10-g Semmes–Weinstein monofilament was

used to identify peripheral sensory neuropathy. The ten-point test was used. The upper part of
the foot, plantar aspect of the hallux and third digit together with the 1st, 3rd and 5th metatarsal
heads were used for testing. With the eyes closed, the patient reported to the investigator
when he or she could feel the monofilament. Participants who were unable to feel the 10 gram
monofilaments on greater than or equal to 4 of the 10 points were considered as neuropathic.

Body Mass Index (BMI): is a simple index of weight-for-height that is commonly used to
classify underweight, overweight and obesity in adults. It is defined as the weight in
kilograms divided by the square of the height in meters (kg/m2). It is classified as BMI less
than 18.5 kg/m2 = underweight, BMI ranging from 18.5–24.9 kg/m2 = normal range, BMI
ranging from 25 – 29.9 kg/m2 = overweight and BMI > 30 kg/m2 = obese (48).

Family support: the support diabetic patients got from their family members in caring for
their feet.

18
4.10. Data quality assurance

Content validation of the adapted questionnaire was done by experienced researchers. The
English questionnaire was translated to the Amharic language by language expert translators
then back to the English language to check for consistency. Three MSc graduate students
collected the data. One MSc holder supervised the overall data collection process. Prior to the
data collection, the enumerators and the supervisor received one day training about the data
collection techniques. In addition, the Amharic version questionnaire was pre-tested on 5% (8
diabetic patients) of the calculated sample size two weeks before actual data collection in St.
Paul’s Hospital Millennium Medical College. Ambiguous words and concepts were corrected
accordingly.

Throughout the course of the data collection, interviewers were supervised. Twenty percent of
the collected data were checked by the supervisor daily for completeness and finally, the
principal investigator monitored the overall quality of data collection. The collected data were
reviewed and checked for completeness before data entry; the incomplete data were
discarded.

4.11. Data analysis procedures

Data were checked, coded and entered to Epi-Data Manager version [Link], and were
exported to SPSS version 24 for analysis. Data entry was made by the principal investigator.

Cross-tabulation was done to assess the distribution of cases and controls. The binary logistic
regression model was used to assess the association between the dependent and independent
variables. All variables with P-value < 0.25 were included in the multivariable analysis to
avoid confounders (49). The magnitude of the association was measured by using an Odds
Ratio with its 95% confidence interval. Statistical significance was declared at P- value <
0.05. Finally, the data were presented with texts, tables and graphs.

19
4.12. Ethical consideration

Ethical clearance letter was obtained from the institutional review board of Addis Ababa
University, College of Health Sciences, School of Nursing and Midwifery research
committee. An official letter was submitted to Tikur Anbessa Specialized Hospital, diabetic
clinic and then, permission was obtained from the concerned bodies. Prior to data collection;
Information was given to the participants and participants’ voluntary participation,
confidentiality, anonymity, and freedom to withdraw from the study at any time were assured.
The nature and importance of the study was explained and consents were obtained from the
participants.

4.13. Dissemination of the result

The results of the study will be presented and submitted to Addis Ababa University, College
of Health Sciences, School of Nursing and Midwifery.
A copy of the findings will also be disseminated to Tikur Anbessa Specialized Hospital,
diabetic clinic. There is also a plan to publish the results of the research in reputable national
or international scientific journals.

20
 5. RESULTS

5.1. Socio-demographic characteristics of respondents

A total of 162 diabetic patients were approached and 161 diabetic patients agreed to
participate in the study, resulting in a response rate of 99.4%.
In this study, 53 cases (diabetic patients with foot ulcer) and 108 controls (diabetic
patients without foot ulcer) were interviewed to answer questions from their socio-
demographic, clinical, behavioral and biological backgrounds. The mean age (SD) of the
cases and controls was 50.55 ±16.34 years and 51.48 ± 16.62 years, respectively. Most of
the study participants were in the age group 58-67 years. Among the respondents, 28
(33.7%) cases and 55 (66.3%) controls were males. The socio demographic characteristics
of the study participants are shown in table 1 below.

21
Table 1: Socio demographic characteristics of the study participants attending the diabetic
clinic in TASH, Addis Ababa, Ethiopia, 2019, (n=161).

Variables Cases (%) Controls (%)

Age category in years
18-27 6(28.6) 15(71.4)
28-37 9(45.0) 11(55.0)
38-47 4(30.8) 9(69.2)
48-57 12(32.4) 25(67.6)
58-67 15(34.1) 29(65.9)
> 68 7(26.9) 19(73.1)
Marital status
Married 40(35.7) 72(64.3)
Single 8(22.9) 27(77.1)
Divorced 5(35.7) 9(64.3)
Educational level
No formal education 4(25.0) 12(75.0)
Primary 15(36.6) 26(63.4)
Secondary 7(36.8) 12(63.2)
Above secondary 27(31.8) 58(68.2)
Occupation
Employed 30(40.0) 45(60.0)
Unemployed 23(26.7) 63(73.3)
Residence
Urban 50(32.3) 105(67.7)
Rural 3(50.0) 3(50.0)

22
5.2. Clinical characteristics of respondents

The proportion of type I DM among the cases and controls was 16(34.8%) and 30(65.2%),
respectively. The proportion of cases and controls having DM less than 10 years was 20
(29.0%) and 49 (71.0%) respectively. In addition, the mean + SD year duration of DM among
cases and controls was 13.04+8.44 and 12.47+9.47 respectively. Hypertension was common
among controls (65.5%) compared to cases (34.5%), while foot deformity was higher among
cases (53.8%) compared to controls (46.2%). The proportion of kidney disease was 8
(80.0%) among controls and 2(20.0%) among cases. The proportion of having FBS > 126
mg/dl was higher in controls (71.0%) compared to cases (29.0%). The clinical characteristics
of the respondents are shown in table 2 below.

Table 2: Clinical factors of the study participants attending the diabetic clinic in TASH, Addis
Ababa, Ethiopia, 2019, (n=161).

Variables Cases (%) Controls (%)

Regularly visit a physician
Yes 53(33.1) 107(66.9)
No 0(0.0) 1(100.0)
Treatment kind of DM
Oral hypoglycemic agents 15(30.0) 35(70.0)
Insulin 35(45.5) 42(54.5)
Both 3(8.8) 31(91.2)
Heart disease
Yes 10(34.5) 19(65.5)
No 43(32.6) 89(67.4)
Peripheral neuropathy
Yes 25(56.8) 19(43.2)
No 28(23.9) 89(76.1)
Dyslipidemia
Yes 0(0.0) 9(100.0)
No 53(33.9) 99(65.1)
10 g- monofilament
Positive 24(46.2) 28(53.8)
Negative 29(26.6) 80(73.8)
Nail problems
Nail deformity 14(53.8) 12(46.2)
No nail problems 39(28.9) 96(71.1)
BMI
< 18.5 11(73.3) 4(26.7)
18.5-24.9 5(11.9) 37(88.1)
25-29.9 19(31.1) 42(68.9)
> 30 18(43.2) 25(58.1)

23
The proportion of callus among cases and controls was 11(42.3%) and 15(57.7%)
respectively. The skin problems of the study participants are shown in figure 3 below.

Skin problems
80.0%
11(68.8%) 82(68.9%)
70.0%
15(57.7%)
60.0%
50.0% 11(42.3%)
40.0% Cases
5(31.3%) 37(31.1%)
30.0% Controls

20.0%
10.0%
0.0%
Dry skin Callus No skin problems

Figure 3: Skin problems of the study participants attending the diabetic clinic in TASH, Addis
Ababa, Ethiopia, 2019, (n=161).

The proportion of uncontrolled blood pressure among cases and controls was 34.4% and
65.6% respectively. The proportion of BP status of the respondents is shown in figure 4
below.

80.0%
70.0% 68(68.0%) 40(65.6%)
60.0%
50.0%
40.0% Controlled
32(32.0%) 21(34.4%)
30.0% Uncontrolled

20.0%
10.0%
0.0%
Controls Cases

Figure 4: BP status of the study participants attending the diabetic clinic in TASH, Addis
Ababa, Ethiopia, 2019, (n=161).

24
5.3. Behavioral factors of respondents

The proportion of washing feet on a daily basis among the controls (66.4%) was higher
compared to cases (33.6%). The proportion of inspecting feet entirely was better in controls
(64.8%) compared to cases (35.2%). Controls were getting more family assistance during foot
inspection (64.9%) compared to cases (35.1). The proportion of reading handouts on proper
foot wear was better among controls (63.3%) compared to cases (36.7%), and the proportion
of attending class on foot care was higher in controls (68.8%) compared to cases (31.2%). The
proportion of inspecting shoes for foreign objects or torn linings were greater in controls
(64.8%) compared to cases (35.2%), and the proportion of taking alcohol was more in
controls (66.7%) compared to cases (33.3%). The behavioral factors of the study respondents
are shown in table 3 below.

25
Table 3: Behavioral factors of the study participants attending the diabetic clinic in TASH,
Addis Ababa, Ethiopia, 2019, (n=161).

Variables Cases (%) Controls (%)

Ever wear shoes without socks
Yes 20(28.6) 50(71.4)
No 33(36.3) 58(63.7)
Use moisturizer after washing
Yes 32(35.6) 58(64.4)
No 21(29.6) 50(70.4)
Use moisturizer between toes
Yes 29(43.3) 38(56.7)
No 24(25.5) 70(74.5)
Family assistance in washing
Yes 16(36.4) 28(63.6)
No 37(31.6) 80(68.4)
Read handouts on foot care
Yes 13(20.6) 50(79.4)
No 40(40.8) 58(59.2)
Annual foot examination session by physician
Yes 25(37.3) 42(62.7)
No 28(29.8) 66(70.2)
Regular physical activity
Yes 32(29.6) 76(70.4)
No 21(39.6) 32(60.4)
Frequency of regular physical activity
< 3 times per week 24(38.3) 38(61.7)
> 3 times per week 12(24.4) 34(75.6)
Running
Yes 4(40.00 6(60.0)
No 30(31.6) 65(68.4)
Walking
Yes 29(32.6) 60(67.4)
No 5(31.3) 11(68.8)
Jogging
Yes 4(40.0) 6(60.0)
No 30(31.6) 65(68.4)
Do you smoke
Yes 2(50.0) 2(50.0)
No 51(32.5) 106(67.5)
Foot wear
Well fit 22(34.4) 42(65.6)
Ill fit 31(32.0) 66(68.0)

26
5.4. Biological factors of the study participants

The mean + SD value of cholesterol among cases and controls was 199.38 + 47.87 and 194.61
+ 46.95 respectively. In addition, the mean + SD value of LDL among cases and controls was
152.32 + 24.30 and 142.12 + 33.31 respectively. The biological factors of the respondents are
shown in table 4 below.

Table 4: Biological factors of the study participants attending the diabetic clinic in TASH,
Addis Ababa, Ethiopia, 2019, (n=161).

Variables Cases (%) Controls (%)

Cholesterol
< 200 28(28.6) 70(71.4)
> 200 25(39.7) 38(60.3)
Triglyceride
< 200 31(26.5) 86(73.5)
> 200 22(50.0) 22(50.0)
HDL
35-60 30(27.8) 78(72.2)
< 35 7(53.8) 6(46.2)
> 60 16(40.0) 24(60.0)
LDL
130-160 31(39.2) 48(60.8)
< 130 5(12.8) 34(87.2)
> 160 17(39.5) 26(60.5)

27
5.5. Factors associated with diabetic foot ulcer

5.5.1. Bivariate analysis of factors affecting diabetic foot ulcer

Binary logistic regression was done for each factors of diabetic foot ulcer among diabetic
patients as shown in the following tables.

[Link]. Bivariate analysis of socio-demographic characteristics

Bivariate analysis was carried out to assess the association of socio-demographic variables.
Among the socio-demographic variables, occupation was a candidate variable for
multivariable logistic regression model at p- value < 0.25. The bivariate analysis of socio-
demographic characteristics of the respondents is shown in table 5 below.
Table 5: Bivariate analysis of the socio-demographic characteristics of study participants
attending the diabetic clinic in TASH, Addis Ababa, Ethiopia, 2019, (n=161).
Variables Cases (%) Controls (%) COR (95% CI) P-value
Sex
Male 28(33.7) 55(66.3) 1.08(0.56-2.08) 0.82
Female 25(32.1) 53(67.9) 1
Age category:
18-27 6(28.6) 15(71.4) 1
28-37 9(45.0) 11(55.0) 2.05(0.56-7.46) 0.28
38-47 4(30.8) 9(69.2) 1.11(0.25-5.04) 0.89
48-57 12(32.4) 25(67.6) 1.20(0.37-3.87) 0.76
58-67 15(34.1) 29(65.9) 1.29(0.42-4.02) 0.66
> 68 7(26.9) 19(73.1) 0.92(0.26-3.32) 0.90
Marital status
Married 40(35.7) 72(64.3) 1.88(0.78-4.51) 0.37
Single 8(22.9) 27(77.1) 1
Divorced 5(35.5) 9(64.3) 1.88(0.49-7.22) 0.36
Educational level
No formal education 4(25%) 12(75%) 0.72(0.21-2.43) 0.59
Primary 15(36.6%) 26(63.4%) 1.24(0.57-2.71) 0.59
Secondary 7(36.8) 12(63.2%) 1.25(0.44-3.54) 0.67
Above secondary 27(31.8) 58(68.2%) 1
Occupation
Employed 30(40.0) 45(60.0) 1
Unemployed 23(26.7) 63(73.3) 0.55(0.28-1.06) 0.08
Area of residence
Urban 8(32.3%) 105(67.7%) 1
Rural 3(50.0%) 3(50.0%) 2.10(0.40-10.78) 0.37

28
[Link]. Bivariate analysis of clinical factors

Bivariate analysis was carried out to assess the association of clinical factors. Among the
clinical factors; kind of treatment of DM taking, peripheral neuropathy, nail problems and
foot deformity were candidate variables for multivariable logistic regression model at p- value
< 0.25. The bivariate analysis of clinical factors of the respondents is shown in table 6 below.
Table 6: Bivariate analysis of the clinical factors of study participants attending the diabetic
clinic in TASH, Addis Ababa, Ethiopia, 2019, (n=161).
Variable Cases (%) Controls COR (95% CI) P-value
(%)
Category of DM
Type I 16(34.8%) 30(65.2%) 1
Type II 37(32.2%) 78(67.8%) 0.89(0.43-1.83) 0.75
Duration of DM
< 10 years 20(29.0%) 49(71.0%) 1
> 10 years 33(35.9%) 59(64.1%) 1.34(0.70-2.68) 0.36
Treatment kind of DM
Oral hypoglycemic agents 15(30.0) 35(70.0) 1
Insulin 35(45.5) 42(54.5) 1.94(0.92-4.13) 0.08
Both 3(8.8) 31(91.2) 0.23(0.06-0.85) 0.03
Hypertension
Yes 20(34.5) 38(65.5) 1.12(0.57-2.21) 0.75
No 33(32.0) 70(68.0) 1
Heart disease
Yes 10(34.5) 19(65.5) 1.09(0.47-2.54) 0.84
No 43(32.6) 89(67.4) 1
Peripheral neuropathy
Yes 19(45.2) 23(54.8) 4.18(2.01-8.70) 0.00
No 30(25.2) 89(74.8) 1
Kidney disease
Yes 2(20.0) 8(80.0) 0.49(0.10-2.39) 0.38
No 51(33.8) 100(66.2) 1
Skin problems
Dry skin 5(31.3) 11(68.8) 1.00(0.33-3.11) 0.99
Callus 11(42.3) 15(57.7) 1.63(0.68-3.88) 0.27
No skin problems 37(31.1) 82(68.9) 1
Nail problems
Nail deformity 14(53.8) 12(46.2) 2.87(1.22-6.76) 0.02
No nail problems 39(28.9) 96(71.1) 1
Foot deformity
Yes 7(53.8) 6(46.2) 2.59(0.82-8.13) 0.10
No 46(31.1) 102(68.9) 1

29
[Link]. Bivariate analysis of behavioral factors

Bivariate analysis was carried out to assess the association of behavioral factors. Among the
behavioral factors; inspecting feet daily, using moisturizer between toes, reading handouts on
foot care, and regular physical activity were candidate variables for multivariable logistic
regression model at p- value < 0.25. The bivariate analysis of behavioral factors of the
respondents is shown in table 7 below.

Table 7: Bivariate analysis of the behavioral factors of study participants attending the
diabetic clinic in TASH, Addis Ababa, Ethiopia, 2019, (n=161).

Variables Controls Cases COR (95% CI) P-value

(%) (%)
Ever walk barefoot
Yes 2(50.0) 2(50.0) 2.08(0.29-15.18) 0.47
No 51(32.5) 106(67.5) 1
Ever wear shoes without socks
Yes 20(28.6) 50(71.4) 0.70(0.36-1.38) 0.30
No 33(36.3) 58(63.7) 1
Always inspect your shoes for
foreign objects or torn linings
Yes 37(35.2) 68(64.8) 0.74(0.36-1.49) 0.39
No 16(28.6) 40(71.4) 1
Inspect your feet daily
Yes 23(21.9) 82(78.1) 1
No 30(53.6) 26(46.4) 4.11(2.04-8.28) 0.00
Inspect your feet entirely
Yes 31(35.2) 57(64.8) 1
No 22(30.1) 51(69.9) 0.79(0.41-1.54) 0.49
Family assistance during
inspection
Yes 13(35.1) 24(64.9) 1
No 40(32.3) 84(67.7) 0.88(0.41-1.90) 0.74
Wash your feet daily
Yes 50(33.6) 99(66.4) 1
No 3(25.0) 9(75.0) 0.67(0.17-2.55) 0.55
Use moisturizer after washing
Yes 32(35.6) 58(64.4) 1
No 21(29.6) 50(70.4) 0.76(0.39-1.48) 0.42

30
Putting moisturizer between toes
Yes 29(43.3) 38(56.7) 2.23(1.14-4.35) 0.02
No 24(25.5) 70(74.5) 1
Family assistance during washing
Yes 16(36.4) 28(63.6) 1
No 37(31.6) 80(68.4) 0.81(0.39-1.68) 0.57
Attend class on foot care
Yes 24(31.2) 53(68.8) 1
No 29(34.5) 55(65.5) 1.16(0.60-2.25) 0.65
Read handouts on foot care
Yes 13(20.6) 50(79.4) 1
No 40(40.8) 58(59.2) 2.65(1.28-5.51) 0.01
Ever read handouts on proper
foot wear
Yes 18(36.7) 31(63.3) 1
No 35(31.2) 77(68.8) 0.78(0.39-1.58) 0.50
Annual foot examination session
by physician
Yes 25(37.3) 42(62.7) 1
No 28(29.8) 66(70.2) 0.71(0.37-1.38 0.32
Regular physical activity
Yes 32(29.6) 76(70.4) 1
No 21(39.6) 32(60.4) 1.56(0.78-3.10) 0.21
Do you smoke
Yes 2(50.0) 2(50.0) 2.08(0.29-15.18) 0.47
No 51(32.5) 106(67.5) 1
Do you take alcohol
Yes 2(33.3) 4(66.7) 1.02(0.18-5.75) 0.98
No 51(32.9) 104(67.1) 1
Foot wear
Well fit 22(34.4) 42(65.6) 1
Ill fit 31(32.0) 66(68.0) 0.90(0.46-1.75) 0.75

31
5.5.2. Multivariable analysis of factors affecting diabetic foot ulcer

Model was checked for fitness using Hosmer and Lemshow test and the p- value was 0.97.

The multivariable analysis displayed in the table 9 below shows that after controlling the
possible confounders; occupation, kind of treatment for DM, putting moisturizing cream
between toes, daily inspection of foot and peripheral neuropathy were statistically significant
with diabetic foot ulcer at p-value < 0.05.

The risk of developing DFU among employed diabetic patients was 65% less likely to occur
compared to diabetic patients who were unemployed [AOR: 0.35, CI: 0.14-0.87, p=0.03].
Diabetic patients taking insulin alone were 2.75 times more likely to develop DFU compared
to diabetic patients taking oral hypoglycemic agents [AOR: 2.75, CI: 1.04-7.23].
Diabetic patients taking both insulin and oral hypoglycemic agents were 89% less likely to
develop DFU compared to diabetic patients taking oral hypoglycemic agents [AOR: 0.11, CI:
0.02-0.57, P=0.01].
Diabetic patients who have peripheral neuropathy were 7.56 times more risk to develop DFU
than diabetic patients without peripheral neuropathy [AOR = 7.56; 95% CI: 2.82-20.24,
P=0.00].
Diabetic patients who did not inspect their feet daily were 5.61 times more risk to develop
DFU than diabetic patients who inspect their feet daily [AOR = 5.61; 95% CI: 2.24-14.05,
P=0.00].
Diabetic patients who use moisturizing cream between their toes were 3.35 times more likely
to develop DFU compared to diabetic patients who did not use moisturizing cream between
their toes [AOR: 3.35, CI: 1.35-8.32, P=0.01].

32
Table 8: Bivariate and multivariable logistic regression for determinants of diabetic
foot ulcer among diabetic patients attending the diabetic clinic in TASH, Addis Ababa,
Ethiopia, 2019, (n=161).
Variables Cases Controls COR (95% CI) P- AOR (95% CI) P-
(%) (%) value value
Occupation
Employed 30(40.0) 45(60.0) 1 1
Unemployed 23(26.7) 63(73.3) 0.55(0.28-1.06) 0.08 0.35(0.14-0.87)** 0.03
Treatment kind
of DM
Oral hypoglycemic 15(30.0) 35(70.0) 1 1
agents
Insulin 35(45.5) 42(54.5) 1.94(0.92-4.13) 0.08 2.75(1.04-7.23)** 0.04
Both 3(8.8) 31(91.2) 0.23(0.06-0.85)* 0.03 0.11(0.02-0.57)** 0.01
Peripheral
neuropathy
Yes 23(54.8) 19(45.2) 4.18(2.01-8.70)* 0.00 7.56(2.82-20.24)** 0.00
No 30(25.2) 89(74.8) 1 1
Inspect your feet
daily
Yes 23(21.9) 82(78.1) 1 1
No 30(53.6) 26(46.4) 4.11(2.04-8.28)* 0.00 5.61(2.24-14.05)** 0.00
Putting
moisturizer
between your toes
Yes 29(43.3) 38(56.7) 2.23(1.14-4.35)* 0.02 3.35(1.35-8.32)** 0.01
No 24(25.5) 70(74.5) 1 1
Reading handout
on foot care
Yes 13(20.6) 50(79.4) 1 1
No 40(40.8) 58(59.2) 2.65(1.28-5.51)* 0.01 1.36(0.53-3.52) 0.52
Regular physical
activity
Yes 32(29.6) 76(70.4) 1 1
No 21(39.6) 32(60.4) 1.56(0.78-3.10) 0.21 1.52(0.58-4.02) 0.40
Nail problems
Nail deformity 14(53.8) 12(46.2) 2.87(1.22-6.76)* 0.02 2.61(0.86-7.96) 0.09
No nail problem 39(28.9) 96(71.1) 1 1
Foot deformity
Yes 7(53.8) 6(46.2) 2.59(0.82-8.13) 0.10 2.89(0.55-15.28) 0.21
No 46(31.1) 102(68.9) 1 1
Note: *= variables with p value of < 0.05 in bivariate analysis and ** = variables that show
significant association in multivariable logistic regression analysis at p-value < 0.05
1 = reference

33
 6. DISCUSSIONS

The main purpose of this study was to assess determinants of diabetic foot ulcer among
diabetic patients attending the diabetic clinic in Tikur Anbessa Specialized Hospital, Addis
Ababa, Ethiopia, 2019. The identified determinants were: occupation, kind of treatment of
DM, putting moisturizing cream between toes, daily inspection of foot and peripheral
neuropathy.

In this study, the risk of developing diabetic foot ulcer among employed diabetic patients was
65% less likely to occur compared to diabetic patients who were unemployed [AOR: 0.35, CI:
0.14-0.87, p=0.03]. This finding is similar to the cross-sectional study done in Arbamich
Hospital, Ethiopia, that states, diabetic patients who were farmers were 6.54 times more to
develop DFU than employed (AOR 6.542, 95% CI: 2.841-49.035) (4). But this finding is
inconsistent with the cross-sectional study conducted in University of Gondar Referral
Hospital, Ethiopia, that showed occupation was not significantly associated with DFU (12),
this discrepancy could be due to difference in sample size and study design.

In this study, diabetic patients taking insulin alone were 2.75 times more likely to develop
diabetic foot ulcer compared to diabetic patients taking oral hypoglycemic agents [AOR: 2.75,
CI: 1.04-7.23]. This finding is consistent with research findings conducted in: Iran with a
prospective cohort study that reveals, insulin usage [AOR: 5.78, CI: 2.37–14.07, P < 0.01]
was having a statistically significant relationship with the incidence of DFU (38), Eastern
Indonesia with a case control study that states diabetic patients taking insulin were 9.37 times
more risk to develop diabetic foot ulcer compared to diabetic patients taking oral
hypoglycemic agents [AOR:9.37, 95% CI: 2.240-39.182] (39). But inconsistent with the
studies conducted in: Saudi Arabia with a cross-sectional study that states, taking insulin was
not significant risk factor for the development of DFU (23), Malaysia with a case-control
study that showed insulin treatment was not a significant determinant of DFU (35), and with
a cross-sectional study conducted in University of Gondar Referral Hospital, Ethiopia, that
showed taking insulin was not significantly associated with DFU (12). This discrepancy could
be due to difference in sample size, study design and disease condition.

34
In this study, diabetic patients taking combined medication (insulin and oral hypoglycemic
agents) were 89% less likely to develop diabetic foot ulcer compared to diabetic patients
taking oral hypoglycemic agents [AOR: 0.11, CI: 0.02-0.57, P=0.01]. This contradicts with
research findings conducted in: Iraq with a cross-sectional study that showed that using a
combination of insulin and oral antidiabetic agents were significantly associated with the
development of DFUs (34), Pakistan with a cross-sectional study that states, combination of
both insulin and oral hypoglycemic agents were strongly associated with the development of
diabetic foot ulcer (40). Malaysia with a case-control study that showed combination of both
insulin and oral hypoglycemic agents were not significantly associated with DFU (35), and
Eastern Indonesia with a case control study that states taking both insulin and oral
hypoglycemic agents were not significantly associated with DFU [AOR: 2.38, 95% CI: 0.507
- 11.199] (39). This discrepancy might be due to the differences in sample size and study
designs.

In this study, diabetic patients who have peripheral neuropathy were 7.56 times more risk to
develop diabetic foot ulcer than diabetic patients without peripheral neuropathy [AOR = 7.56;
95% CI: 2.82-20.24, P=0.00]. This finding is consistent to the studies conducted in: Australia
with a cross sectional study, that reveals diabetic patients with peripheral neuropathy were
1.77 times more risk to develop diabetic foot ulcer than diabetic patients without peripheral
neuropathy [AOR:1.77, CI: 1.09-2.86] (33), Iran with a prospective cohort study that reveals,
diabetic patients with distal neuropathy were 3.37 times more risk to develop diabetic foot
ulcer than diabetic patients without neuropathy [AOR: 3.37, CI: 1.40-8.09, P= 0.007] (38),
Pakistan with a cross-sectional study states, development of diabetic foot ulcer was strongly
associated with neuropathy among diabetic patients with neuropathy than diabetic patients
without neuropathy (40), and University of Gondar Referral Hospital, Ethiopia, with a cross
sectional study that reveals diabetic patients who have neuropathy were 21.76 times more risk
to develop DFU than diabetic patients who have no neuropathy [AOR:21.76, CI: 8.43-57.47)]
(12). This condition is inevitable as patients with neuropathy could sustain minor trauma
without being aware of the injury until it worsens. It had been suggested that this condition
can be prevented by wearing proper foot wear, maintaining hygiene and performing daily
physical examination.

35
But inconsistent to the studies conducted in: Saudi Arabia with a cross-sectional study that
states, neuropathy was not significantly associated with the development of diabetic foot ulcer
[AOR: 0.42, CI: 0.05–3.44, p: 0.421] (23), and Arbaminch Hospital, Ethiopia, with cross
sectional study design states that neuropathy was not significantly associated with the
development of diabetic foot ulcer (4). This discrepancy might be due to differences in
diabetes mellitus duration, and study design.

In this study, diabetic patients who did not inspect their feet daily were 5.61 times more risk
to develop diabetic foot ulcer than diabetic patients who inspect their feet daily [AOR = 5.61,
95% CI: 2.24-14.05, P=0.00]. This is consistent with the case control study conducted in
Eastern Indonesia that states, diabetic patients who inspect their feet were 64% less risk to
develop diabetic foot ulcer than diabetic patients who did not inspect their feet daily [AOR:
0.36, CI: 0.186-0.703] (39). These findings indicate the importance of daily feet inspection to
prevent risk factors. This finding is also consistent with the International Working Group on
the Diabetic Foot (IWGDF) guideline that states, risk patients with diabetes should inspect
their feet daily (8). But this is inconsistent with the cross sectional study conducted in Iraq
that states, daily feet inspection was not significantly associated with the development of
diabetic foot ulcer [p= 0.172] (34). This discrepancy might be due to difference in study
design and participants behavior in inspecting feet.

In this study, diabetic patients who use moisturizing cream between their toes were 3.35 times
more likely to develop diabetic foot ulcer compared to diabetic patients who did not use
moisturizing cream between their toes [AOR: 3.35, CI: 1.35-8.32, P=0.01]. Though there are
no studies that show the association of putting cream between toes and diabetic foot ulcer, this
finding is consistent with the guideline Diabetes Foot: Risk Assessment Education Program
Participant’s Package that states ―do not put cream between the toes‖(50).

36
 7. STRENGTHS AND LIMITATIONS OF THE STUDY

7.1. Strength of the study

 It attempted to assess determinants of diabetic foot ulcer using a stronger study design
from other studies conducted in Ethiopia. Because previous studies were cross
sectionals.

7.2. Limitations of the study

 The retrospective nature of collecting information about some of the variables is prone
to recall bias.
 It was difficult to get laboratory records of the biologic factors that were taken before the
occurrence of the outcome of interest.

37
 8. CONCLUSIONS AND RECOMMENDATIONS

8.1. Conclusions

This study identified risk factors for diabetic foot ulcer as: taking insulin alone, peripheral
neuropathy, not inspecting feet daily, and putting moisturizing cream between toes, were
positively associated with diabetic foot ulcer. Whereas employed and taking both insulin and
oral hypoglycemic agents were negatively associated with diabetic foot ulcer.

8.2. Recommendations

Based on the study findings, the following recommendations are forwarded.

To TASH

 It is encouraged if TASH strengthens annual foot examination session for diabetic

patients that will help to reduce the rate of diabetic foot ulcer.
To health care providers
 It will be advantageous if health care providers provide extra advice to diabetic
patients to wear appropriate foot wear.

To diabetic patients
 It will be beneficial if diabetic patients inspect their feet daily.
 It will be better if diabetic patients do not put moisturizing cream between their
toes.

To upcoming researchers

 A prospective cohort study is encouraged to establish the temporal relationship of

biologic factors with diabetic foot ulcer.

38
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Healthy Foot Screen: A Novel Assessment Tool for Common Clinical Abnormalities.
Advances in Skin & Wound Care [Internet]. 2018 Apr [cited 2019 Jan 27]; 31(4):154–62.
Available from:

[Link]

48. World Health Organization. Global Database on Body Mass Index - World Health
Organization [Internet]. 2006 [cited 2019 Jan 5]. Available from:

[Link]

49. Bursac Z, Gauss CH, Williams DK, Hosmer DW. Purposeful selection of variables in
logistic regression. Source Code for Biology and Medicine [Internet]. 2008 Dec [cited
2019 Feb 15]; 3(1):1–8. Available from:

[Link]

50. Alwyn Moyer, Lillian Delmas, Margaret Little, Denise Williams. Diabetes Foot: Risk
Assessment Education Program Participant’s Package. Registered Nurses Association of
Ontario. 2004 Mar; 1–22.

47
 [Link]

10.1. Appendix I: Information sheet (English version)

Addis Ababa University

College of Health Sciences
School of Nursing and Midwifery
Postgraduate Program
Good morning!
My name is ______. Here, I am here representing Guesh Teklu, Adult Health Nursing Student
at Addis Ababa University, College of Health Sciences, School of Nursing and Midwifery,
Graduate Study Program, and he is conducting a research on a topic entitled as Determinants
of diabetic foot ulcer among adult diabetic patients attending the diabetic clinic in Tikur
Anbessa Specialized Hospital, 2019.

I am inviting you to participate in this research. You may choose to take part or not and if you
chose to, you are free to withdraw from the study at any time during the study. If you do not
want to take part, your care in the hospital will not be affected by your decision.

The necessary information regarding the study is mentioned below.

Purpose of the study: the purpose of this study is to assess the determinants of diabetic foot
ulcer among adult diabetic patients attending the diabetic clinic in Tikur Anbessa Specialized
Hospital.

Participants to be included: all consecutive diabetic patients attending the diabetic clinic in
Tikur Anbessa Specialized Hospital during the study period will be recruited until sample size
is achieved.

Benefits and risks of the study:

Benefits: For your participation in the study no payment will be granted or has no special
privilege to you. Your responses to the following questions are beneficial to you and other
diabetic patients as input in identifying risk factors for diabetic foot ulcers and will contribute
a role in improving diabetic foot care in accordance with the findings.

48
Risks: Your participation will not expose you to any harm. The study will be conducted
through interviews and you will assist me in completing the questionnaire. I will ask you
some questions and your answer will help me to fill the forms. The questions are easy and
will take about 25 – 30 minutes to complete the forms. I will also use the opportunity to look
at your feet to identify any problem.

Confidentiality: The questionnaire is completely anonymous, your name will not be

mentioned in the questionnaire and you cannot be identified in any way. The information you
will provide is confidential and will only be available to me and my supervisor. It will not
also be disclosed to the third party.

If you have questions regarding this study or would like to be informed of the results after its
completion, you are welcome to contact me on the number and e-mail address below. And if
you are willing to take part in this study, you are required to sign the consent form attached.

Name and Address of the principal investigator:

Guesh Teklu Woldemariam

Cell phone: +251-9-33-05-26-93, E-mail: gueshomt21@[Link]

Name and Address of the main advisors:

Niguse Tadele
Cell phone: +251-9-13-16-31-30, E-mail: [Link]@[Link]
Dr. Getahun Tarekegn
Cell phone: +251-9-11-40-55-17, E-mail: gtarekegn@[Link]
Name and Address of the co-advisor:
Yosef Tsige
Cell phone: +251-9-11-30-58-24, E-mail: josephtsige@[Link]

Are you willing to participate in this study?

_________Yes, I want to participate in the study (Please go to the next page).
_________ No, I do not want to participate in the study (Thank you very much).

49
10.2. Appendix II: Consent form (English version)

In undersigning this document, I am giving my consent to participate in the study. I have been
informed that the purpose of this study is to assess the determinants of diabetic foot ulcer
among diabetic patients attending the diabetic clinic in Tikur Anbessa Specialized Hospital. I
have understood that participation in this study is entirely voluntary and my identity will not
be disclosed to the third party. I have also been informed that my participation or my refusal
to take part will not affect the care I receive from the hospital. I understood that participation
in this study imposes no risk to me. I understood that Guesh Teklu is the contact person if I
have questions about the study or about my rights as a study participant.

Now I am giving my consent to participate in the study voluntarily.

Signature of the participant ______________________ Date____/______/____

Data collector

Name ____________________________ Signature ________Date____/______/____

50
10.3. Appendix III: Questionnaire (English version)

Part I: Socio-demographic characteristics of respondents

Code: __________

Instruction: Please circle the provided responses

Status (from patient card): 1. Control 2. Case

S. No: Question Response

101 Sex 1. Male

2. Female
102 Age
103 Marital status 1. Single
2. Married
3. Separated
4. Divorced
5. Widowed
104 Educational level 1. No formal education
2. Primary (1-8)
3. Secondary (9-10)
4. Above secondary
105 Occupation 1. Private
2. Governmental employee
3. Farmer
4. Housewife
5. Daily labor
7, Others (specify)------
106 Area of residence 1. Urban
2. Rural

51
Part II: Clinical factors related questions

S. No: Question Response Remark

201 Which category of diabetes do you have? 1. Type I
(from patient card) 2. Type II
202 Duration of diabetes mellitus ___________ years
203 Do you visit your physician regularly for 1. Yes
evaluation and treatment of your diabetes? 2. No
204 Kind of treatment of DM taking 1. Insulin
2. Oral hypoglycemic
agents
3. Both
7, Other (specify)
205 Do you have another known disease? 1. Yes
2. No
206 If yes to 205, what type of known disease? 1. Hypertension
2. Heart disease
3. Peripheral neuropathy
7, Others (specify)
207 Blood pressure SBP ____ mmHg
DBP _____ mmHg
208 Weight _______ Kg
209 Height _______ m
210 Body Mass Index (BMI) ______ Kg/m2
211 Fasting Blood Glucose ______ mg/dl
212 10 g- Monofilament 1. Positive
2. Negative
213 Skin problems 1. Dry skin
2. Callus
3. Tinea pedis
4. No
214 Nail problems 1. Nail Deformity
2. Onychomycosis
3. No
215 Does the patient have foot deformity? 1. Yes
2. No

52
Part III: Behavioral factors related questions

S. No: Question Response

301 Do you ever walk around in your bare feet? 1. Yes
2. No
302 Do you ever wear shoes without wearing any socks? 1. Yes
2. No
303 Do you always inspect your shoes for foreign objects or 1. Yes
torn linings? 2. No
304 Do you inspect your feet daily? 1. Yes
2. No
305 Do you inspect your feet entirely? 1. Yes
2. No
306 Do you get family assistance during feet inspection? 1. Yes
2. No
307 Do you wash your feet daily? 1. Yes
2. No
308 Do you use moisturizer after feet washing? 1. Yes
2. No
309 Do you use moisturizing cream between your toes? 1. Yes
2. No
310 Do you get family assistance during feet washing? 1. Yes
2. No
311 Have you ever attended a class on how to care for your 1. Yes
feet? 2. No
312 Have you ever read any handouts on foot care? 1. Yes
2. No
313 Have you ever read any handouts on proper footwear? 1. Yes
2. No
314 Do you have an annual foot examination session by 1. Yes 2. No
professional?
315 Do you do physical activity on a regular basis? 1. Yes 2. No
316 If yes to 315, how many times per week? _____ times per week
317 If yes to 315, what kind of exercise? 1. Running
2. Walking
3. Jogging
7, Others (specify)
318 Do you smoke? 1. Yes 2. No
319 Do you take alcohol? 1. Yes 2. No
320 If yes to question 319, could you measure it? 1. Every day
2. Once per week
3. Once per month
7, Others (specify)
321 Foot wear 1. Well fit
2. Ill fit

53
Part IV: Biologic factors of the respondents (laboratory results)

S. No: Question Response

501 Total cholesterol mg/dl
502 Triglyceride mg/dl
503 HDL mg/dl
504 LDL mg/dl

Thank you for your cooperation!!

Results:
1. Questionnaire completed _________
2. Questionnaire partially completed ________________
3. Participant refused ____________
4. Others (Specify) ___________
Checked by Supervisor:
Name________________________________ Signature ___________ Date____/____/___

54
10.4. Appendix IV: Information sheet (Amharic Version)

ተጨማሪ መግሇጫዎች
አዱስ አበባ ዩኒቨርሲቲ
ጤና ሳይንስ ኮላጅ
የነርሲንግ እና ሚዴዋይፇሪ ትምህርት ቤት
የዴህረ - ምረቃ መርሃ ግብር
አባሪ I: የመረጃ ሰነዴ

ጤና ይስጥሌኝ!!
ስሜ __________________ እባሊሇሁኝ፡፡ እዚህ የተገኘሁት በአዱስ አበባ ዩኒቨርሲቲ ጤና ሳይንስ ኮላጅ በነርሲንግ እና
ሚዴዋይፇሪ ትምህርት ቤት የዴህረ ምረቃ መርሃ ግብር ተማሪ የሆኑት ጉዕሽ ተክለን ወክዬ ነው፡፡ እሳቸውም በጥቁር
አንበሳ ስፔሻሊይዝዴ ሆስፒታሌ የስኳር ህመም ማእከሌ በሚከታተለ ታካሚዎች ሁርያ የእግር ቁስሇትን በሚያጋሌጡ
ነገሮች ሊይ ጥናት እያካየደ ይገኛለ፡፡ በዚህ ጥናት እንዱሳተፈ እጋብዛችኋሇሁኝ፡፡ ተሳታፉ ሇመሆንም ሊሇመሆንም
መምረጥ ይችሊለ፡፡ ከፇሇጉ በጥናቱ ወቅት በማንኛውም ጊዜ ጥናቱን ማቋረጥ ይችሊለ፡፡ እርስዎ ሇመሳተፌ
ካሌፇሇጉ,በውሳኔዎ ምክንያት በሆስፒታለ ውስጥ በሚያገኙት እንክብካቤ ሊይ ሇውጥ አያመጣም፡፡
ስሇ ጥናቱ አስፇሊጊ መረጃ ከዚህ በታች ተዘርዝሯሌ፡፡
የጥናቱ ዓሊማ፣ የዚህ ጥናት ዓሊማ በጥቁር አንበሳ ስፔሻሊይዝዴ ሆስፒታሌ የስኳር ህመም ማእከሌ በሚከታተለ
ታካሚዎች ሇእግር ቁስሇት የሚያጋሌጡ ነገሮችን ሇመገምገም ነው.፡፡
ተሳታፉዎች፣ በጥናቱ ወቅት በጥቁር አንበሳ ስፔሻሊይዝዴ ሆስፒታሌ የስኳር ህመም ማእከሌ የሚከታተለ ታካሚዎች
የጥናቱ ጥቅሞች እና ጉዲቶች፣
ጥቅሞች፣ በጥናቱ ሲሳተፈ ክፌያ አይሰጥዎትም ወይም ሌዩ ሌዩ መብት አይኖርዎትም፡፡ ይሁን እንጂ መሌስዎ ሇእርስዎ
እና ሇላልች የስኳር ታካሚዎች ሇእግር ቁስሇት የሚያጋሌጡ ነገሮች ሇማወቅ ያግዛሌ፡፡ እንዱሁም በግኝቶቹ መሰረት
የስኳር ህመም የእግር ቁስሇት እንክብካቤ ሇማሻሻሌ ከፌተኛ አስተዋጽኦ ይኖረዋሌ፡፡
ጉዲቶች፣ ተሳትፍዎ ወዯ ማንኛውም ጉዲት አያጋሌጥም፡፡ ጥናቱ የሚካሄዯው በቃሇ-መጠይቆች ሲሆን መጠይቁን
በመመሇስ ያግዙኛሌ፡፡ እኔ ጥያቄዎችን እጠይቅዎታሇሁ እና መሌሶችዎ ቅፆቹን ሇመሙሊት ያግዘኛሌ፡፡ ጥያቄዎቹ ቀሊሌ እና
ቅፆቹን ሇማጠናቀቅ 25 – 30 ዯቂቃዎችን ይወስዲለ፡፡ በተጨማሪም ማንኛውንም ችግር ሇማወቅ እግርዎን ሇመመሌከት
እዴለን እጠቀማሇሁ፡፡
ሚስጢራዊነት፣ መጠይቁ ሙለ ሇሙለ ስም ኣይፃፌበትም እናም ስምዎ በመጠይቁ ውስጥ አይጠቀስም፡፡ በምንም
መሌኩ ሉታወቅ አይችሌም፡፡ የሚሰጡት መረጃ በምስጢር የሚያዝ እና ሇእራሴ እና ሇአሇቃዎቼ ብቻ ነው የሚነሆው፡፡
ሇሶስተኛ ወገን አይገሇፅም.፡፡
ይህንን ጥናት በተመሇከተ ጥያቄ ካሇዎት ወይም ከተጠናቀቀ በኋሊ ስሇ ውጤቶቹ መረጃ እንዱሰጥዎት ከፇሇጉ ከዚህ በታች
ባሇው ቁጥር እና ኢሜሌ አዴራሻ ሉያገኙ ይችሊለ፡፡ በዚህ ጥናት ሇመሳተፌ ፇቃዯኛ ከሆኑ, በስምምነት ቅፁ በመፇረም
ይተባበሩን፡፡

55
የዋናው ተማራማሪ ስም እና አዴራሻ፡
ስም፡ ጉዕሽ ተክለ ወሌዯማርያም
ተንቀሳቃሽ ስሌክ፡ +251-9-33-05-26-93› ኢሜሌ፡ gueshomt21@[Link]

የዋናው አማካሪዎች ስምና አዴራሻ፡

ስም፡ ንጉሰ ታዯሇ
ተንቀሳቃሽ ስሌክ፡ +251-9-13-16-31-30› ኢሜሌ፡ [Link]@[Link]
ስም፡ ድ/ር ጌታሁን ታረቀኝ›
ተንቀሳቃሽ ስሌክ፡ +251-9-11-40-55-17› ኢሜሌ፡ gtarekegn@[Link]

የተባባሪ አማካሪ ስም እና አዴራሻ፡

ስም፡ ዮሴፌ ፅጌ
ተንቀሳቃሽ ስሌክ: +251-9-11-30-58-24› ኢሜሌ፡ josephtsige@[Link]

በዚህ ጥናት ሇመሳተፌ ፇቃዯኛ ነዎት?

_________ ኣዎ, በጥናቱ ውስጥ መሳተፌ እፇሌጋሇሁ (እባክዎ ወዯ ቀጣዩ ገጽ ይሂደ)
_________ አይ, በጥናቱ ውስጥ መሳተፌ አሌፇሌግም (በጣም አመሰግናሇሁ)

56
10.5. Appendix V: Consent form (Amharic Version)

አባሪ II፡ የስምምነት ቅፅ

በዚህ ሰነዴ ሊይ በመሇያዬ ሇመሳተፌ ፇቃዯኛነቴን እሰጣሇሁ. የዚህ ጥናት ዓሊማ በጥቁር አንበሳ ስፔሻሊይዝዴ ሆስፒታሌ
የስኳር ህመም ማእከሌ በሚከታተለ ታካሚዎች ሇእግር ቁስሇት የሚያጋሌጡ ነገሮችን ሇመገምገም እንዯሆነ
ተነግሮኛሌ.፡፡
በዚህ ጥናት መሳተፌ ሙለ በሙለ በፇቃዴ ውስጥ የተካተተ እንዯሆነና የእኔን ማንነት ሇሶስተኛ ወገን እንዯማይሰጥ
ተረዴቻሇሁ፡፡ በተጨማሪም የእኔ መሳተፌ ወይም ኣሇመሳተፌ በሆስፒታለ ከሚያገኘው እንክብካቤ ጋር ምንም ችግር
እንዯላሇው ተነግሮኛሌ፡፡ በዚህ ጥናት ውስጥ መሳተፌ ሇኔ ምንም ችግር እንዯማይፇጥር ተረዴቼያሇሁ፡፡ ስሇ ጥናቱ
ወይም እንዯ ተሳታፉ ስሇ መብቶቼን አስመሌክቶ ጥያቄዎች ካለኝ ጉዕሽ ተክለ ተጠሪ መሆኑን ተረዴቻሇው፡፡ .
አሁን በፇቃዯኝነት በጥናቱን ሇመሳተፌ ፇቃዯኛነቴን ሰጥቻሇሁ፡፡

የተሳታፉው ፉርማ ______________________ ቀን ____ / ______ / ____

መረጃ ሰብሳቢ

ስም __________________________ ፉርማ ________ ቀን ____ / ______ / ____

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10.6. Appendix VI: Questionnaire (Amharic Version)

አባሪ III፡ መጠይቅ

ክፌሌ I-የተሳታፉው ማህበራዊ እና ኢኮኖሚያዊ ባህርያት

ኮዴ: __________
መመሪያ: እባክዎ የተሰጡትን ምሊሾች ያክብቡ
የታካሚው ሁኔታ (ከታካሚው ካርዴ)፡ 1. የእግር ቁስሇት የላሇው 2. የእግር ቁስሇት ያሇው
ተራ ቁጥር ጥያቄ መሌስ

101 ፆታ 1. ወንዴ
2. ሴት
102 ዕዴሜ

103 የጋብቻ ሁኔታ 1. ያሊገባ/ች

2. ያገባ/ች
3. የተሇያዩ
4. የተፊታ/ች
5. የሞተችበት/ባት
104 የትምህርት ዯረጃ 1. ያሌተማረ
2. ኣንዯኛ ዯረጃ (1ኛ - 8ኛ)
3. ሁሇተኛ ዯረጃ (9ኛ - 10ኛ)
4. ከሁሇተኛ ዯረጃ በሊይ
105 ስራ 1. የግሌ
2. የመንግሥት ሠራተኛ
3. ገበሬ
4. የቤት እመቤት
5. የቀን ሰራተኛ
7, ላልች (ይጥቀሱ) ------
106 የመኖሪያ አካባቢ 1. ከተማ
2. ገጠር

58
ክፌሌ II: ከክሉኒካሌ ምክንያቶች ጋር ተያያዥነት ያሊቸው ጥያቄዎች

ተራ ቁጥር ጥያቄ መሌስ ማብራሪያ

201 የትኛው የስኳር ህመም ዓይነት አሇዎት? 1. ዓይነት I
(ከታካሚው ካርዴ) 2. ዓይነት II
202 የስኳር ህመምዎ ስንት ዓመት ሁኖታሌ? ____________
203 ሇስኳርዎ ምርመራ እና ሕክምና 1. አዎ
በመዯበኛነት ሀኪምዎን ይጎበኛለ? 2. አይ
204 ምን ዓይነት የሱኳር መዴሃኒት ይወስዲለ? 1. በመርፋ (ኢንሱሉን)
2. በአፌ የሚዋጥ
3. ሁሇቱም
7, ላሊ (ይጥቀሱ)
205 ላሊ የታወቀ በሽታ አሇዎት? 1. አዎ
2. አይ
206 መሌስዎ አዎ ከሆነ, ምን ዓይነት በሽታ ነው? 1.የዯም ግፉት
2. የሌብ ህመም
3. የነርቭ ችግር
7, ላልች (ይጥቀሱ)
207 የዯም ግፉት SBP _____ mmHg
DBP _____ mmHg
208 ክብዯት Kg
209 ቁመት m
210 የሰውነት ብዛትን መሇኪያ (BMI) Kg/m2
211 የፆም የዯም ግለኮስ መጠን mg / dl
212 10 g- Monofilament 1. ኣሇ
2. የሇም
213 የቆዲ ችግሮች 1. ዯረቅ ቆዲ (Dry skin)
2. የቆዲ መጅ፣ ጠጠር ያሇ ነገር
(Callus)
3. የእግር ፇንገስ (Tinea pedis)
4. አይ
214 የጥፌር ችግሮች 1. የጥፌር መበሊሸት (Nail
Deformity)
2. የጥፌር ፇንገስ
(Onychomycosis)
3. አይ
215 ታካሚው የእግር መበሊሸት ችግር ኣሇው ? 1. አዎ
2. አይ

59
ክፌሌ III: ከተሳታፉዎች ባህሪያት ጋር ተያያዥነት ያሊቸው ጥያቄዎች

ተራ ቁጥር ጥያቄ መሌስ

301 በባድ እግርዎ ይጓዛለ? 1. አዎ
2. አይ
302 ያሇካሌሲ ጫማ ያረጋለ? 1. አዎ
2. አይ
303 በጫማዎ ውስጥ የውጭ የሆኑ ዕቃዎች እንዲይኖሩት ወይም የተቀዯደ 1. አዎ
እንዲይሆኑ ይፇትሻለ? 2. አይ
304 በየቀኑ እግርዎን ይመረምራለ? 1. አዎ
2. አይ
305 እግርዎን ሙለ በሙለ ይመረምራለ? 1. አዎ
2. አይ
306 እግርዎን በሚመረምሩበት ወቅት የቤተሰብ ዴጋፌ ያገኛለ? 1. አዎ
2. አይ
307 እግርዎን በየቀኑ ይታጠባለ? 1. አዎ
2. አይ
308 እግርዎ ከታጠቡ በኋሊ የቆዲ ቅባት ይጠቀማለ? 1. አዎ
2. አይ
309 በጣተዎ መሃሌ የቆዲ ቅባት ይጠቀማለ? 1. አዎ
2. አይ
310 እግርዎ በሚታጠቡበት ወቅት የቤተሰብ ዴጋፌ ያገኛለ? 1. አዎ
2. አይ
311 እግርዎ እንዳት እንዯሚንከባከቡ ትምህርት ተሰጥተዎት ያውቃሌ? 1. አዎ
2. አይ
312 ስሇ እግር እንክብካቤ የተፃፇ ጽሑፌ አንብበው ያውቃለ? 1. አዎ
2. አይ
313 ስሇ ተገቢ ጫማ ኣጠቃቀም የተፃፇ ጽሑፌ አንብበው ያውቃለ? 1. አዎ
2. አይ
314 በየአመቱ እግርዎ በባሇሙያ ይታያለ? 1. አዎ 2. አይ
315 ዘወትር አካሊዊ እንቅስቃሴ ያዴርጋለ? 1. አዎ 2. አይ
316 ሇ 315 መሌስዎ አዎ ከሆነ, በሳምንት ስንት ጊዜ? _________ ጊዜ በሳምንት
317 ሇ 315 መሌስዎ አዎ ከሆነ, ምን ዓይነት እንቅስቃሴ? 1. ሩጫ
2. የእግር ጉዞ
3. ቀሊሌ ሩጫ (Jogging)
7, ላልች (ይጥቀሱ)
318 ያጨሳለ? 1. አዎ 2. አይ
319 አሌኮሌ ይወስዲለ? 1. አዎ 2. አይ
320 ሇመጠየቅ 319 ኣዎ ከሆነ, መጠኑን ስንት ነው? 1. በየቀኑ
2. በሳምንት አንዳ
3. በወር አንዴ ጊዜ
7, ላልች (ይጥቀሱ)
321 ጫማዎች 1. በሚገባ የገጠሙ
2. በሚገባ የገጠሙ ኣይዯለም

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ክፌሌ IV: የተሳታፉዎች ባዮልጂካዊ ምክንያቶች (የሊቦራቶሪ ውጤቶች)

ተራ ቁጥር ጥያቄ መሌስ

501 ጠቅሊሊ ኮላስትሮሌ mg / dl
502 Triglyceride mg / dl
503 HDL mg / dl
504 LDL mg / dl

ሇትብብርዎ ኣመሰግናሇሁ፡፡

ዉጤት:
1. መረጃው ሙለ በሙለ ተሰብስቧሌ _________
2.መረጃው በከፉሌ ተሰብስቧሌ ________________
3. ተሳታፉው እምቢ ብሎሌ ____________
4. ላልች (ይጥቀሱ) ___________
ተቆጣጣሪ፡

ስም __________________________ ፉርማ ________ ቀን ____ / ______ / ____

61