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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Withdrawn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
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 5, 2020
    Last Updated
    October 14, 2022
    Sponsor
    University Hospital, Lille
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    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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