Foot Care Assessment and Relation to Diabetic Complications

Assiut University

Status: Unknown

Conditions: Diabetic Foot

Treatments: Behavioral: integrated foot care program

Study type: Interventional

Funder types: Other

Identifiers

NCT05040009

Foot care assessment in DM

Details and patient eligibility

About

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

Full 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

Enrollment: 259 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

259 participants in 2 patient groups

moderate and high risk patient with integrated foot care program

Active Comparator group

Description:

Integrated foot care program will be applied to moderate and high-risk patients for diabetic foot with follow up after 6-12 months 1. Regular foot care and examination by an adequately trained professional: - 2. Structured education 3. Adequate footwear 4. Foot-related exercises and weight-bearing activity. 5. Foot examination and screening every 4 months in moderate risk and 2 months in high-risk patient for diabetic foot. 6. Instructions about foot self-management

Treatment:

Behavioral: integrated foot care program

moderate and high risk patient with conventional treatment

No Intervention group

Description:

conventional treatment will be applied to moderate and high-risk patients for diabetic foot with follow up after 6-12 months.