Actively Recruiting
Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
Led by University of Michigan · Updated on 2025-09-18
40
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial 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 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
Official Title
Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed and dated informed consent
- Willingness to comply with all study procedures and be available for the study duration
- Male or female, aged 18 years or older
- Diagnosed with or meets criteria for type 2 diabetes
- Have a diabetic foot ulcer larger than 0.5 cm² and less than 12 cm², located at least 2 cm from any other ulcer
- Ulcer classified as Wagner grade 1 or 2
- If multiple ulcers present, the largest qualifying ulcer will be selected
You will not qualify if you...
- Participation in another interventional clinical trial within 1 month before visit 1
- Charcot's foot or foot deformities preventing proper ulcer offloading
- Active severe infection or osteomyelitis at screening
- History of cancer within 3 years except non-melanoma skin cancer
- Use of adjunctive therapy in the previous 30 days
- Currently taking systemic glucocorticoid medication
- Planned or recent vascular intervention on the same side within 1 month
- Pregnant or currently lactating
- Uncontrolled blood glucose with urinary ketones present
- Contraindications for exercise per American Heart Association/American College of Sports Medicine guidelines
- Bilateral wounds or ulcers
- Current COVID-19 infection
- Any medical condition that would compromise safe study completion as judged by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
School of Kinesiology
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
J
Jacob Haus, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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