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

• ClinicalTrials.gov Identifier: NCT04582357
• Recruitment Status: Not yet recruiting
• First Posted: October 9, 2020
• Last Update Posted: October 14, 2020
• Sponsor: University Hospital, Lille
• Information provided by (Responsible Party): University Hospital, Lille

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

France

Hop Claude Huriez Chu Lille

Lille, France, 59037

Contact 0320445962

Sponsors and Collaborators

University Hospital, Lille

Investigators

• Principal Investigator: Florence Baudoux, MD; University Hospital, Lille

More Information

• 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
• Last Update Posted: October 14, 2020
• Last Verified: September 2020

• 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:

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