Home-Based Exercise to Improve Functional Outcomes in Veterans With a Recently Healed Diabetic Foot Ulcer: Protocol for a Pilot Randomized Controlled Trial.

Background: Foot ulcers are a common complication of diabetes, often resulting from peripheral neuropathy and inadvertent trauma. Poor healing is exacerbated by peripheral arterial disease and poor glycemic control. Off-loading, a key treatment, leads to prolonged immobility. Patients rarely regain baseline mobility. Mobility is crucial to improve glycemia, promote vascular health, and improve immobility as it leads to nursing home admissions. There is limited research on exercise during ulcer remission.

Objective: This pilot study will assess the feasibility and acceptability of a home-based exercise regimen aimed at safely increasing mobility and function, focusing on improving lower extremity strength, tissue perfusion, and glycemic control.

Methods: Veterans aged ≥50 years with a recently healed diabetic plantar foot ulcer receiving care in the US Department of Veterans Affairs (VA) Maryland Health Care System and enrolled in a remote temperature-sensing mat program will be eligible. Potential participants will be identified via administrative codes used for the Prevention of Amputation in Veterans Everywhere directive, as well as using the VA's Podimetrics SmartMat dashboard. In this pilot study, 25 veterans will be randomized (in a 3:1 ratio) to a 12-week home-based exercise regimen or standard of care. Participants will undergo tests for gait speed, knee extension strength, cutaneous perfusion, and community mobility. The intervention group will participate in internet-based videoconference exercise classes twice a week led by the study team and home cycling 3 times a week. The control group will receive standard-of-care guidance. Outcome measures will include feasibility; acceptability; and changes in gait speed, physical activity levels, and strength.

Results: This study was funded on July 1, 2024, with data collection planned from October 1, 2024, to March 31, 2026. The protocol was approved by the University of Maryland Institutional Review Board on May 13, 2024, and by the Baltimore VA Research and Development Committee on June 13, 2024. As of June 12, 2025, 12 participants have been enrolled in the study, and 6 (50%) participants have been randomized. Recruitment is expected to continue through December 2025.

Conclusions: This project has potential for clinical rehabilitation translation. If it is found to be feasible and acceptable, the exercise intervention will be tested in a future multisite randomized clinical trial to assess its impact on mobility, cardiovascular events, and ulcer recurrence.

Trial registration: ClinicalTrials.gov NCT06312579; https://clinicaltrials.gov/ct2/show/NCT06312579.

International registered report identifier (irrid): DERR1-10.2196/71237.