Foot Care Assessment and Relation to Diabetic Complications

Study Overview
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Brief Summary
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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
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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 Medical history. Therapeutic history: Antidiabetic drugs (type, duration), other medications for obesity, hypertension and dyslipidemia Complete physical examination. 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) 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

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

Conditions
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Diabetic Foot

Intervention / Treatment
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* Behavioral: integrated foot care program


Participation Criteria
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Eligibility Criteria
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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 75. Pregnant diabetic women. Connective tissue disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: moderate and high risk patient with integrated foot care program<br>Integrated foot care program will be applied to moderate and high-risk patients for diabetic foot with follow up after 6-12 months Regular foot care and examination by an adequately trained professional: - Structured education Adequate footwear Foot-related exercises and weight-bearing activity. Foot examination and screening every 4 months in moderate risk and 2 months in high-risk patient for diabetic foot. Instructions about foot self-management | Behavioral: integrated foot care program<br>* Regular foot care and examination by an adequately trained professional: - Structured education: Educational modality will be provided to patients in a structured way. This will take many forms: one-to-one verbal education session last around 30 min motivational interviewing, video education, booklets, pictorial education via animated drawing or descriptive images structured foot care education consists of information on: Foot ulcers and their consequences Preventative foot self-care behaviors Wearing adequately protective footwear Undergoing regular foot checks Practicing proper foot hygiene Seeking professional help in a timely manner after identifying a foot problem 3-Adequate footwear 4-Foot-related exercises and weight-bearing activity 5-Foot examination and screening 6- Instructions about foot self-management<br>|
| No Intervention: moderate and high risk patient with conventional treatment<br>conventional treatment will be applied to moderate and high-risk patients for diabetic foot with follow up after 6-12 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integrated foot care program in moderate and high-risk patients for diabetic foot versus conventional treatment | moderate and high risk patients for diabetic foot will undergo integrated program vs conventional treatment as regard ulcer healing and recurrence | 6 to 12 month | 
| Evaluation of knowledge and practice of diabetic foot using questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC) | knowledge and practice are assessed using questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC) | baseline | 
| Screening for diabetic foot and diabetic complication in patients attending at Diabetic center | 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) | baseline |