NCT05603273 · University of Michigan
Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
What this study is about
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 randomly assigned clinical trial will determine how blood flow to the ulcer and whole body metabolism may be improved with exercise.
View original scientific 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.
Interventions
BEHAVIORAL
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 measures
wound size and depth
Time frame: 6 weeks
wound site and depth
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of signed and dated informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or Female, aged 18 yrs or older
- Diabetes diagnosed or meets ADA criteria for Type 2 diabetes
- 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
- In case of multiple ulcers, select the largest ulcer that meets inclusion criteria.
Exclusion criteria
- Patient participating in an interventional clinical trial within 1 month of visit 1
- Participant has Charcot's foot or other foot deformities that prevent adequate targeted ulcer offloading
- Participant has active severe infection or osteomyelitis at the time of the screening visit
- History of cancer within the last 3 years, other than non-melanoma skin cancer
- Use of adjunctive therapy within previous 30 days
- Currently receiving medication considered to be a systemic glucocorticoid
- Plan to perform a vascular intervention, such as surgical bypass, angioplasty or stenting, or \< 1 month from a prior ipsilateral (same side) vascular intervention
- Pregnant or currently lactating
- Uncontrolled blood glucose with presence of urinary ketones
- Contraindications for exercise as define by the American Heart Association/American College of Sports Medicine Guidelines for Exercise Testing and Prescription \[1\]
- Bilateral wound or ulcer
- Current infection of COVID19
- Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participants ability to safely complete the study
Where
- Ann Arbor, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 18, 2025 · Source of record for eligibility and locations