Home-Based Exercise to Improve Functional Outcomes in Veterans With a Recently Healed Diabetic Foot Ulcer: Protocol for a Pilot Randomized Controlled Trial
Bibliographic record
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 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.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.020 | 0.019 |
| Meta-epidemiology (narrow) | 0.006 | 0.002 |
| Meta-epidemiology (broad) | 0.012 | 0.006 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.005 | 0.008 |
| Insufficient payload (model declined to judge) | 0.067 | 0.009 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".