Physical Activity Assessment of Patients With Diabetic Foot Wounds (EFADDIAP)
Primary Purpose
Diabetic Foot
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical activity program
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetic foot, Physical activity, Muscular mass, Cicatrization, Offloading
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise arm
Arm Description
This arm is the only arm of the study, every patient is included in this arm, the patients will follow the physical activity program
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Glycated hemoglobin variation
Evaluation of the glycated hemoglobin before inclusion and at the end of the study, to evaluate the diabet's metabolical balance
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
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
Security
Patients will report any unexpected event or any injury in the log book, like hypoglycaemia or pain
Full Information
NCT ID
NCT04582357
First Posted
October 5, 2020
Last Updated
October 14, 2022
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT04582357
Brief Title
Physical Activity Assessment of Patients With Diabetic Foot Wounds
Acronym
EFADDIAP
Official Title
Offloaded Physical Activity Program Feasibility Assessment of Patients With Diabetic Foot Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
sponsor decision
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
Keywords
Diabetic foot, Physical activity, Muscular mass, Cicatrization, Offloading
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise arm
Arm Type
Experimental
Arm Description
This arm is the only arm of the study, every patient is included in this arm, the patients will follow the physical activity program
Intervention Type
Behavioral
Intervention Name(s)
Physical activity program
Intervention Description
The physical activity program is a suite of several exercises which intend to improve muscular mass of targeted muscles.
Primary Outcome Measure Information:
Title
Physical activity program attendance
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Glycated hemoglobin variation
Description
Evaluation of the glycated hemoglobin before inclusion and at the end of the study, to evaluate the diabet's metabolical balance
Time Frame
3 months
Title
Wound size variation
Description
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
Time Frame
3 months
Title
Quality of life variation
Description
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
Time Frame
3 months
Title
Security
Description
Patients will report any unexpected event or any injury in the log book, like hypoglycaemia or pain
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence Baudoux, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Physical Activity Assessment of Patients With Diabetic Foot Wounds
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