Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-02 @ 8:53 AM
Study NCT ID:
NCT04582357
Status:
WITHDRAWN
Last Update Posted:
2022-10-18
First Post:
2020-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity Assessment of Patients With Diabetic Foot Wounds
Sponsor:
University Hospital, Lille
Organization:
Study Overview
Official Title:
Offloaded Physical Activity Program Feasibility Assessment of Patients With Diabetic Foot Wounds
Status:
WITHDRAWN
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFADDIAP
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-A02274-35 | OTHER | ID-RCB number,ANSM | View |