NCT05603273 Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers
| NCT ID | NCT05603273 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Type2diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2025-06-30 |
Trial Parameters
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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.
Eligibility Criteria
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. Cur
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