Physical Activity Assessment of Patients With Diabetic Foot Wounds

NCT ID: NCT04582357

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-31
• Study Completion Date: 2021-12-31

Brief Summary

The study evaluates the compliance of patients who suffer from a diabetic foot wound to follow a physical activity program, adapted to their medical condition.

This study will aslo evaluate the security of this program, and how it could improve or not the quality of life, the diabet's metabolical balance, and the wounds's cicatrization speed.

Detailed Description

The study is a prospective monocentric study, leaded in the Lille CHRU. this study is a physical activity program feasibility assessment for patients with diabetic foot wounds. The muscular mass stabilization and the physical activity is almost never used to heal diabetic feet wounds. With this study, we evaluate the compliance of patients to follow a physical activity program, which could lead to a further study, with more patients and multicentric, and it could measure the impact of this program on metabolical balance, wound size and quality of life.

The study will last 6 months, the inclusion will last 3 months, and each patient will have a 3 months follow-up time. The patient have several medical appointments in the diabetic foot unit, where the compliance will be evaluated, wound size and security will also be evaluated.

The activity program is a suite of exercises, 4 times in a week, it lasts 30 minutes?

The first day, follow-up book is given to the patient. During the follow-up, the patient will still have his usual medical appointments, which will occur at the 30th, 60th and 90th days.

Phone-call appointments will also be possible at the 15th and 45th days.

Conditions

Diabetic Foot

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise arm

This arm is the only arm of the study, every patient is included in this arm, the patients will follow the physical activity program

Group Type: EXPERIMENTAL

Physical activity program

Intervention Type: BEHAVIORAL

The physical activity program is a suite of several exercises which intend to improve muscular mass of targeted muscles.

Interventions

Physical activity program

The physical activity program is a suite of several exercises which intend to improve muscular mass of targeted muscles.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Men and women
• Every patient over 18 years old
• Diabet whatever the type, with foot wound, whatever the size, or duration.

Exclusion Criteria

• Medical condition : sub-gonal amputation, which makes physical activity impossible. Wound localization which would lead to a wound degradation, like the heel, the plantar face of toes.
• Administrative cause : impossibility to provide written informed consent, impossibility to be followed up during the needed duration, no medical insurance, rejection to sign the consent paper.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence Baudoux, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Other Identifiers

2020-A02274-35

Identifier Type: OTHER

Identifier Source: secondary_id

2019_67

Identifier Type: -

Identifier Source: org_study_id