Clinical trial NCT04582357: Physical Activity Assessment of Patients With Diabetic Foot Wounds
Official title: Offloaded Physical Activity Program Feasibility Assessment of Patients With Diabetic Foot Wounds
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Foot
Keywords: Diabetic foot
Physical activity
Muscular mass
Cicatrization
Offloading
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Physical activity program attendance
timeFrame: 3 months
Secondary outcomes:
measure: Glycated hemoglobin variation
timeFrame: 3 months
measure: Wound size variation
timeFrame: 3 months
measure: Quality of life variation
timeFrame: 3 months
measure: Security
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Florence Baudoux, MD
role: PRINCIPAL_INVESTIGATOR
References: