Physical Activity Assessment of Patients With Diabetic Foot Wounds

Diabetic Foot Clinical Trial

— EFADDIAP  

Official title:

Offloaded Physical Activity Program Feasibility Assessment of Patients With Diabetic Foot Wounds

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04582357
• Other study ID #: 2019_67
• Secondary ID: 2020-A02274-35
• Status: Withdrawn
• Phase: N/A
• Start date: December 2020
• Est. completion date: December 2021

Study information

• Verified date: September 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity program attendance	This outcome will evaluate the rate of patients who followed the whole physical activity program, with the help of a log book, which will be given to the patient at the first appointment	3 months
Secondary	Glycated hemoglobin variation	Evaluation of the glycated hemoglobin before inclusion and at the end of the study, to evaluate the diabet's metabolical balance	3 months
Secondary	Wound size variation	The wound is measured with a graduated scale before inclusion and at the end of the study, the main axis is used to define the size	3 months
Secondary	Quality of life variation	The quality of life will be measured with a simple survey before inclusion and at the end of the study, the survey is the DFS scale. the DFS evaluates the quality of life with questions like emotional impact, pain, personal satisfaction	3 months
Secondary	Security	Patients will report any unexpected event or any injury in the log book, like hypoglycaemia or pain	3 months