Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers

Description

The goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care. This randomized clinical trial will determine how blood flow to the ulcer and whole body metabolism may be improved with exercise. Participants will be randomized to either exercise + standard wound care or standard wound care alone and undergo testing for leg blood flow, fitness and measures of metabolism through blood draws. The intervention period is 6-weeks. Eligible participants must have an existing foot ulcer uncomplicated by infection and be medically cleared to exercise.

Conditions

Type2diabetes, Foot Ulcer

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Study Overview

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Study Details

Study overview

The goal of this study is to improve the therapeutic management of diabetic foot ulcers (DFU). The main questions to answer are if a program of non-weight bearing exercise helps the DFU heal faster than standard wound care. This randomized clinical trial will determine how blood flow to the ulcer and whole body metabolism may be improved with exercise. Participants will be randomized to either exercise + standard wound care or standard wound care alone and undergo testing for leg blood flow, fitness and measures of metabolism through blood draws. The intervention period is 6-weeks. Eligible participants must have an existing foot ulcer uncomplicated by infection and be medically cleared to exercise.

Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers

Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers

Condition
Type2diabetes
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

School of Kinesiology, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Provision of signed and dated informed consent
  • 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  • 3. Male or Female, aged 18 yrs or older
  • 4. Diabetes diagnosed or meets ADA criteria for Type 2 diabetes
  • 5. Foot ulcer of diabetic etiology, with all of the following characteristics:
  • * Ulcer size \> 0.5cm2 and \< 12cm2 at least 2 cm from any other ulcer
  • * Ulcer with Wagner grade 1 or 2
  • 6. In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.
  • 1. Patient participating in an interventional clinical trial within 1 month of visit 1
  • 2. Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloading
  • 3. Participant has active severe infection or osteomyelitis at the time of the screening visit
  • 4. History of cancer within the last 3 years, other than non-melanoma skin cancer
  • 5. Use of adjunctive therapy within previous 30 days
  • 6. Currently receiving medication considered to be a systemic glucocorticoid
  • 7. Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \< 1 month from a prior ipsilateral (same side) vascular intervention
  • 8. Pregnant or currently lactating
  • 9. Uncontrolled blood glucose with presence of urinary ketones
  • 10. Contraindications for exercise as define by the American Heart Association/American College of Sports Medicine Guidelines for Exercise Testing and Prescription \[1\]
  • 11. Bilateral wound or ulcer
  • 12. Current infection of COVID19
  • 13. Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participants ability to safely complete the study

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Jacob Haus, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2026-06-30