Recruiting

Non-weight Bearing Exercise

Sponsor:

University of Michigan

Code:

NCT05603273

Conditions

Type2diabetes

Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

non-weight bearing exercise

Study Details

Brief summary:

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

Study ID

NCT05603273

Start date

Dec 13, 2023

Status verified date

Sep, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: standard wound care

normal wound care according to current clinical practice

experimental: non-weight bearing exercise + standard wound care

normal wound care according to current clinical practice with the addition of a weekly exercise routine

Interventions

non-weight bearing exercise

exercise on a non-weight bearing device at 50% of peak capacity, 3 days per week for 6 weeks

Primary outcome measure

  • wound size and depth [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

School of Kinesiology

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

More Information

Sponsor

University of Michigan

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-09-18.