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Prevalence and Associated Factors of Diabetic Foot Ulcers Among Diabetic Patients Attending Al-Jemaih Diabetic Center, Dongola, Northern State, Sudan, 2026

ETH-20261014-0212 تاريخ التقديم: Oct 14, 2026 / Submitted: Oct 14, 2026
قيمة الرسوم / Payment Amount
6,000.00 SDG
نوع البحث / Research Type
بكالوريوس / Bachelor's
فترة الدراسة / Study Period
Oct 15, 2026 - Dec 06, 2026
Approved
السودان - الولاية الشمالية
وزارة الصحة
الادارة العامة للتخطيط والتنمية الصحية
إدارة البحوث
لجنة الموافقة الأخلاقية
طلب الموافقة الأخلاقية - Ethical Approval Request Form
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Ethical Approval Request Form
General Administration for Planning and Health Development
Research Department
Ethical Approval Committee
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رقم التسلسل
Serial Number
SER-20261014-0212
رقم الطلب
Request Number
ETH-20261014-0212
تاريخ تقديم الطلب
Date of Submission
2026-10-14

القسم الأول: معلومات الباحث / Principal Investigator Information

1. الاسم الكامل للباحث الرئيسي
Principal Investigator Full Name
Mohammed Amir Mohammed Diab
2. الجهة التي ينتمي إليها
Affiliation Type
جامعة / University: University of Dongola - Faculty of Medicine and Health Sciences
University of Dongola - Faculty of Medicine and Health Sciences
3. الوظيفة / اللقب العلمي
Job Title/Academic Degree
-
4. البريد الإلكتروني
Email Address
mohammed.a.diab2@gmail.com
5. رقم الهاتف
Phone Number
0913601536
المشرف / Supervisor
الاسم الكامل / Full Name
Mohammed Ismail Abdelmotalab
البريد الإلكتروني / Email
mmotalab707@yahoo.com
الوظيفة / اللقب العلمي / Job Title
Assistant Professor
رقم الهاتف / Phone
0916189909
القسم / المؤسسة / Department
Clinical Pharmacology department

القسم الثاني: تفاصيل الدراسة البحثية / Research Study Details

7. عنوان الدراسة
Study Title
Prevalence and Associated Factors of Diabetic Foot Ulcers Among Diabetic Patients Attending Al-Jemaih Diabetic Center, Dongola, Northern State, Sudan, 2026
8. نوع البحث (يرجى التحديد)
Type of Research (Please select)
☐دكتوراه / PhD
☐ماجستير / Master's
☑بكالوريوس / Bachelor's
☐دبلوم عالي / Postgraduate Diploma
☐دبلوم وسيط / Intermediate Diploma
☐ورقة علمية / Research Paper
☐تقرير علمي / Scientific Report
☐أبحاث طبية / Medical Research
☐أخرى / Other
9. وصف مختصر للبحث
Brief Description of Research
Research ObjectivesGeneral objective: Determine the prevalence and associated factors of diabetic foot ulcers (DFU) among patients at Al-Jemaih Diabetic Center, Dongola.Specific objectives:Estimate the prevalence of DFU among participants.Describe sociodemographic and clinical characteristics (age, sex, residence, diabetes type/duration, comorbidities, BMI, blood pressure).Assess foot-care practices (daily inspection, footwear, barefoot walking, education). Identify sociodemographic, clinical, and behavioral risk factors (e.g., smoking, physical activity, hypertension, obesity). MethodologyDesign: Facility-based, descriptive analytical cross-sectional study.Population: Adults (≥18 years) with type 1 or type 2 diabetes attending Al-Jemaih Diabetic Center.Sample size: 360 patients, calculated using prevalence data from River Nile State (12.7%).Sampling technique: Systematic random sampling from daily clinic lists. Data collection tools:Structured Arabic questionnaire (sociodemographic, clinical, lifestyle, foot-care).Anthropometric and blood pressure measurements.Direct foot inspection to confirm ulcers.Record review for glucose/HbA1c and comorbidities.Analysis: SPSS v27; prevalence with 95% CI; chi-square and logistic regression to identify associated factors.Ethics: Approval from Northern State Ministry of Health; informed consent; confidentiality maintained. Expected OutcomesFirst local estimate of DFU prevalence in Dongola.Identification of modifiable risk factors (e.g., smoking, poor foot care, uncontrolled diabetes).Evidence to guide screening, patient education, and referral programs at Al-Jemaih Center and Northern State Ministry of Health.Baseline data for future prospective studies and policy planning.Contribution to reducing DFU-related complications such as amputation, poor quality of life, and high treatment costs.

القسم الثالث: الجوانب الأخلاقية / Ethical Considerations

10. طريقة الحصول على الموافقة من المشاركين
Method of Obtaining Consent from Participants
☐مكتوبة / Written
☑شفهية / Verbal
☐غير مطبقة / Not Applicable
☐ضمنية / Implied
☐إعفاء / Waiver
يرجى إرفاق نموذج الموافقة / Please attach consent form
11. آلية الحفاظ على سرية المعلومات
Confidentiality Measures
Confidentiality MeasuresNo identifying data recorded: Names or personal identifiers will not be written on questionnaires; participants will be identified only by codes.Secure storage: Completed forms will be kept in a locked location accessible only to the research team.Privacy during procedures: Interviews and measurements will be conducted respectfully, with same‑sex staff where possible, to maintain cultural sensitivity.Voluntary participation: Participants can refuse or withdraw at any time without affecting their care. Data Security MeasuresRestricted access: Only the research team will handle raw data.Minimal risk procedures: Interviews, weight/height, and blood pressure measurements are non‑invasive.Immediate referral: Participants found with active ulcers will be referred promptly for medical care, ensuring ethical responsibility.Purpose limitation: Data will be used solely for this research and shared only with Al‑Jemaih Center and the Northern State Ministry of Health.
12. مدى المخاطر على المشاركين
Risk Level to Participants
☐لا توجد / None
☑طفيفة / Minor
☐متوسطة / Moderate
☐عالية / High
يرجى توضيح أي مخاطر محتملة وخطة التعامل معها / Please describe any potential risks and mitigation:
-
13. الفوائد المحتملة للمشاركين أو المجتمع
Potential Benefits to Participants or Society
Benefits to ParticipantsClinical awareness: Participation helps patients reflect on their diabetes management and foot‑care practices, potentially improving self‑care.Early detection: Direct foot inspection may identify ulcers that patients were unaware of, leading to timely referral and treatment.Health education: All participants will receive brief advice on proper foot care, reducing their risk of future complications. Benefits to the Healthcare System & SocietyLocal prevalence data: Provides the first estimate of DFU prevalence in Dongola, filling a critical knowledge gap.Risk factor identification: Highlights modifiable factors (e.g., smoking, poor glycemic control, barefoot walking) that can be targeted in prevention programs.Policy guidance: Results will inform the Northern State Ministry of Health in planning screening, education, and referral services. Community health impact: Improved prevention and management reduce amputations, hospital stays, treatment costs, and mortality.Scientific contribution: Adds evidence to the literature on DFU in Sudan and similar low‑resource settings, supporting future research and interventions.
14. هل تشمل الدراسة فئات ضعيفة؟
Does the study involve vulnerable groups?
☐الأطفال / Children
☐النساء الحوامل / Pregnant Women
☐اللاجئون/النازحون / Refugees/Displaced
☐ذوو الإعاقة / People with Disabilities
☐أخرى / Other:

القسم الرابع: قائمة المرفقات المطلوبة / Required Attachments

نسخة من المقترح البحثي الكامل
Full Research Proposal
أدوات جمع البيانات
Data Collection Tools
موافقات أخلاقية من جهات أخرى (إن وُجدت)
Ethical Approval from Other Institutions (if applicable)
نموذج الموافقة
Consent Form
خطاب تسهيل من الجامعة
University Facilitation Letter

القسم الخامس: الإقرار والتوقيع / Acknowledgment and Signature

أُقر أنا الموقع أدناه بأن جميع المعلومات الواردة في هذه الاستمارة صحيحة وكاملة، وأتعهد بعدم البدء في أي جزء من الدراسة قبل الحصول على الموافقة الأخلاقية الرسمية، والالتزام بجميع الإرشادات والمعايير الأخلاقية المعتمدة من قبل لجنة الموافقة الأخلاقية.
I, the undersigned, acknowledge that all information provided in this form is accurate and complete, and I agree not to begin any part of the study before receiving official ethical approval, and to comply with all ethical guidelines and standards approved by the Ethical Approval Committee.
اسم الباحث الرئيسي / Principal Investigator Name
Mohammed Amir Mohammed Diab
التوقيع / Signature
_______________________
التاريخ / Date
2026-10-14

معلومات الباحث / Researcher Information

M

Mohammed Amir Mohammed Diab

mohammed.a.diab2@gmail.com

0913601536

جامعة: University of Dongola الكلية: Faculty of Medicine and Health Sciences

Al-Jemaih Diabetic Center, Dongola

اسم المؤسسة التي سيتم فيها عمل البحث / Name of the institution where the research will be conducted

معلومات الدراسة / Study Information

بكالوريوس / Bachelor's

بكالوريوس - Bachelor

6,000.00 SDG

Research ObjectivesGeneral objective: Determine the prevalence and associated factors of diabetic foot ulcers (DFU) among patients at Al-Jemaih Diabetic Center, Dongola.Specific objectives:Estimate the prevalence of DFU among participants.Describe sociodemographic and clinical characteristics (age, sex, residence, diabetes type/duration, comorbidities, BMI, blood pressure).Assess foot-care practices (daily inspection, footwear, barefoot walking, education). Identify sociodemographic, clinical, and behavioral risk factors (e.g., smoking, physical activity, hypertension, obesity). MethodologyDesign: Facility-based, descriptive analytical cross-sectional study.Population: Adults (≥18 years) with type 1 or type 2 diabetes attending Al-Jemaih Diabetic Center.Sample size: 360 patients, calculated using prevalence data from River Nile State (12.7%).Sampling technique: Systematic random sampling from daily clinic lists. Data collection tools:Structured Arabic questionnaire (sociodemographic, clinical, lifestyle, foot-care).Anthropometric and blood pressure measurements.Direct foot inspection to confirm ulcers.Record review for glucose/HbA1c and comorbidities.Analysis: SPSS v27; prevalence with 95% CI; chi-square and logistic regression to identify associated factors.Ethics: Approval from Northern State Ministry of Health; informed consent; confidentiality maintained. Expected OutcomesFirst local estimate of DFU prevalence in Dongola.Identification of modifiable risk factors (e.g., smoking, poor foot care, uncontrolled diabetes).Evidence to guide screening, patient education, and referral programs at Al-Jemaih Center and Northern State Ministry of Health.Baseline data for future prospective studies and policy planning.Contribution to reducing DFU-related complications such as amputation, poor quality of life, and high treatment costs.

Oct 15, 2026 - Dec 06, 2026

Oct 20, 2026 - Nov 15, 2026

الاعتبارات الأخلاقية / Ethical Considerations

Verbal

مخاطر منخفضة - Low Risk

Confidentiality MeasuresNo identifying data recorded: Names or personal identifiers will not be written on questionnaires; participants will be identified only by codes.Secure storage: Completed forms will be kept in a locked location accessible only to the research team.Privacy during procedures: Interviews and measurements will be conducted respectfully, with same‑sex staff where possible, to maintain cultural sensitivity.Voluntary participation: Participants can refuse or withdraw at any time without affecting their care. Data Security MeasuresRestricted access: Only the research team will handle raw data.Minimal risk procedures: Interviews, weight/height, and blood pressure measurements are non‑invasive.Immediate referral: Participants found with active ulcers will be referred promptly for medical care, ensuring ethical responsibility.Purpose limitation: Data will be used solely for this research and shared only with Al‑Jemaih Center and the Northern State Ministry of Health.

Benefits to ParticipantsClinical awareness: Participation helps patients reflect on their diabetes management and foot‑care practices, potentially improving self‑care.Early detection: Direct foot inspection may identify ulcers that patients were unaware of, leading to timely referral and treatment.Health education: All participants will receive brief advice on proper foot care, reducing their risk of future complications. Benefits to the Healthcare System & SocietyLocal prevalence data: Provides the first estimate of DFU prevalence in Dongola, filling a critical knowledge gap.Risk factor identification: Highlights modifiable factors (e.g., smoking, poor glycemic control, barefoot walking) that can be targeted in prevention programs.Policy guidance: Results will inform the Northern State Ministry of Health in planning screening, education, and referral services. Community health impact: Improved prevention and management reduce amputations, hospital stays, treatment costs, and mortality.Scientific contribution: Adds evidence to the literature on DFU in Sudan and similar low‑resource settings, supporting future research and interventions.