Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 15, 2025
Date Accepted: Aug 12, 2025
Home-based exercise to improve functional outcomes in Veterans with a recently healed diabetic foot ulcer: Protocol for a Pilot Randomized Controlled Trial
ABSTRACT
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 is 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+ with a recently healed (3-27 months) diabetic plantar foot ulcer receiving care in the VA Maryland Health Care System and enrolled in a remote temperature mat program, will be eligible. In this pilot study, 25 Veterans will be randomized to a 12-week home-based exercise regimen or standard of care (3:1 ratio). Participants will undergo tests for gait speed, knee extension strength, cutaneous perfusion, and community mobility. The intervention group will participate in virtual exercise classes twice a week and home cycling three 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:
The study was funded on July 1, 2024, with data collection from October 1, 2024, to March 31, 2026. The protocol was approved by the University of Maryland IRB on May 13, 2024, and by Baltimore VA Research and Development Committee on June 13, 2024.
Conclusions:
This project has potential for clinical rehabilitation translation. If acceptable, the exercise intervention will be tested in a future multi-site randomized clinical trial to assess its impact on mobility, cardiovascular events, and ulcer recurrence. Clinical Trial: ClinicalTrials.gov NCT06312579; https://clinicaltrials.gov/ct2/show/NCT06312579
Citation
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