🏛️ Verified NIH Record • Updated 2025-09-17

Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers (NCT05603273)

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: University of Michigan

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (14 items).

Location: School of Kinesiology — Ann Arbor, Michigan

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

  • non-weight bearing exercise (BEHAVIORAL)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • School of Kinesiology — Ann Arbor, Michigan

📞 Contact the Study Coordinator

Phone: (734) 647-2790

Email: jmhaus@umich.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗