Physical Activity Assessment of Patients With Diabetic Foot Wounds

NCT04582357 | Withdrawn

• 2 other identifiers: 2019_672020-A02274-35
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Foot

Keywords

Diabetic foot; Physical activity; Muscular mass; Cicatrization; Offloading

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (4)

• Glycated hemoglobin variation

  3 months

• Wound size variation

  3 months

• Quality of life variation

  3 months

• Security

  3 months

Study Arms (1)

Exercise arm

EXPERIMENTAL

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

Interventions

Physical activity program BEHAVIORAL

The physical activity program is a suite of several exercises which intend to improve muscular mass of targeted muscles.

Exercise arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• Every patient over 18 years old
• Diabet whatever the type, with foot wound, whatever the size, or duration.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Diabetic Foot; Motor Activity; Cicatrix

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Behavior; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Florence Baudoux, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 9, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 18, 2022

Record last verified: 2020-09