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Clinical Trials/NCT05040009
NCT05040009
Unknown
Not Applicable

Foot Care and Footwear Assessment in Diabetic Patients and Its Relation to Diabetic Complications.

Assiut University1 site in 1 country259 target enrollmentDecember 1, 2021
ConditionsDiabetic Foot

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Foot
Sponsor
Assiut University
Enrollment
259
Locations
1
Primary Endpoint
Integrated foot care program in moderate and high-risk patients for diabetic foot versus conventional treatment
Last Updated
4 years ago

Overview

Brief Summary

Screening for diabetic foot in patients attending at Diabetic center at Assiut university and its relations to diabetic microvascular complications (nephropathy, neuropathy and retinopathy) and macrovascular complications (stroke , myocardial infarction and peripheral arterial diseases).

Footwear assessment in diabetic patient. Evaluation of integrated foot care program in moderate and high-risk patients for diabetic foot.

Evaluation of knowledge and practice of diabetic foot

Detailed Description

The International Diabetes Federation (IDF) has identified Egypt as the ninth leading country in the world for the number of patients with T2D. The prevalence of T2D in Egypt was almost tripled over the last 2 decades. This sharp rise could be attributed to either an increased pattern of the traditional risk factors for T2D such as obesity and physical inactivity and change in eating pattern or other risk factors unique to Egypt . Diabetic foot complications are the most common cause of non-traumatic lower extremity amputations in the industrialized world, may cause death or physical and psychical disability, has a great impact on quality of life, and represents a high cost for society ( . The term diabetic foot encompasses any lesion in the feet: infection, ulcer, and destruction of deep tissues occurring as the result of diabetes and its complications . The absence of symptoms in a person with diabetes does not exclude foot disease; they may have asymptomatic neuropathy, peripheral artery disease, pre-ulcerative signs, or even an ulcer. Every diabetic patient will be subjected to 1. Medical history. 2. Therapeutic history: Antidiabetic drugs (type, duration), other medications for obesity, hypertension and dyslipidemia 3. Complete physical examination. 4. The following work up; * Knowledge questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC) . * Screening for diabetic foot . * Fundus examination * ECG * The following investigations: Alb/cre ration, HBA1c, lipid profile, blood urea, serum creatinine * Abdominal ultrasound * Ankle brachial index (ABI) 5. Integrated foot care program will be applied to moderate and high-risk patients for diabetic foot with follow up after 6-12 months vs conventional education

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
May 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paula Rofaeel Sedky

Assistant lecturer Faculty of Medicine, ِِAssiut University

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Adult patient with diabetic mellitus

Exclusion Criteria

  • Major amputation of lower limbs. End stage organ failure. Diabetic patient less than 18 years or more than
  • Pregnant diabetic women. Connective tissue disease

Outcomes

Primary Outcomes

Integrated foot care program in moderate and high-risk patients for diabetic foot versus conventional treatment

Time Frame: 6 to 12 month

moderate and high risk patients for diabetic foot will undergo integrated program vs conventional treatment as regard ulcer healing and recurrence

Evaluation of knowledge and practice of diabetic foot using questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC)

Time Frame: baseline

knowledge and practice are assessed using questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC)

Screening for diabetic foot and diabetic complication in patients attending at Diabetic center

Time Frame: baseline

Screening for diabetic foot in patients attending at Diabetic centre at Assiut university according to IWGDF guidelines Every diabetic patient will be subjected to Fundus examination ECG The following investigations: Alb/creatinine ratio, HBA1c, lipid profile, blood urea, serum creatinine Abdominal ultrasound Ankle brachial index (ABI)

Study Sites (1)

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