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Physical Activity Assessment of Patients With Diabetic Foot Wounds (EFADDIAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04582357
Recruitment Status : Not yet recruiting
First Posted : October 9, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment Phase
Diabetic Foot Behavioral: Physical activity program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Offloaded Physical Activity Program Feasibility Assessment of Patients With Diabetic Foot Wounds
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise arm
This arm is the only arm of the study, every patient is included in this arm, the patients will follow the physical activity program
Behavioral: Physical activity program
The physical activity program is a suite of several exercises which intend to improve muscular mass of targeted muscles.




Primary Outcome Measures :
  1. Physical activity program attendance [ Time Frame: 3 months ]
    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 :
  1. Glycated hemoglobin variation [ Time Frame: 3 months ]
    Evaluation of the glycated hemoglobin before inclusion and at the end of the study, to evaluate the diabet's metabolical balance

  2. Wound size variation [ Time Frame: 3 months ]
    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. Quality of life variation [ Time Frame: 3 months ]
    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

  4. Security [ Time Frame: 3 months ]
    Patients will report any unexpected event or any injury in the log book, like hypoglycaemia or pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582357


Contacts
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Contact: Florence Baudoux, MD 0320445962 florence.baudoux@chru-lille.fr

Locations
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France
Hop Claude Huriez Chu Lille
Lille, France, 59037
Contact    0320445962      
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Florence Baudoux, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04582357    
Other Study ID Numbers: 2019_67
2020-A02274-35 ( Other Identifier: ID-RCB number,ANSM )
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Diabetic foot
Physical activity
Muscular mass
Cicatrization
Offloading
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies