Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
University of Michigan
40 participants
Dec 13, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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
Exclusion Criteria13
- 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
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Interventions
exercise on a non-weight bearing device at 50% of peak capacity, 3 days per week for 6 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05603273