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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-12-13 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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
Contact & Investigator
Jacob Haus, PhD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT05603273 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Type2diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05603273 currently recruiting?
Yes, NCT05603273 is actively recruiting participants. Contact the research team at jmhaus@umich.edu for enrollment information.
Where is the NCT05603273 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT05603273 clinical trial?
NCT05603273 is sponsored by University of Michigan. The principal investigator is Jacob Haus, PhD at University of Michigan. The trial plans to enroll 40 participants.
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