Foot Care Assessment and Relation to Diabetic Complications

April 13, 2022 updated by: Paula Rofaeel Sedky, Assiut University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

259

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Asyut
      • Assiut, Asyut, Egypt, 088
        • Recruiting
        • Paula Rofaeel
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional 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

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
Behavioral: 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
No Intervention: 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.

What is the study measuring?

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
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
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)
Time Frame: baseline
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
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)
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

August 22, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Foot care assessment in DM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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