Foot Care Assessment and Relation to Diabetic Complications

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-05-31

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

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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

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

Conditions

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Diabetic Foot

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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moderate and high risk patient with integrated foot care program

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

Group Type ACTIVE_COMPARATOR

integrated foot care program

Intervention Type BEHAVIORAL

1. Regular foot care and examination by an adequately trained professional: -
2. 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:

1. Foot ulcers and their consequences
2. Preventative foot self-care behaviors
3. Wearing adequately protective footwear
4. Undergoing regular foot checks
5. Practicing proper foot hygiene
6. 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

moderate and high risk patient with conventional treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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integrated foot care program

1. Regular foot care and examination by an adequately trained professional: -
2. 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:

1. Foot ulcers and their consequences
2. Preventative foot self-care behaviors
3. Wearing adequately protective footwear
4. Undergoing regular foot checks
5. Practicing proper foot hygiene
6. 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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No