NCT06312579

At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers

Home-based Exercise to Improve Functional Outcomes in Veterans With Recently Healed Diabetic Foot Ulcer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Foot ulcers and amputations are a common and feared complication for people with diabetes. People with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer. At least one in four people with a new diabetic foot ulcer will die within five years, largely due to cardiovascular causes. The reasons for this increased mortality involve decreased mobility. People with a recently healed diabetic foot ulcer are considered "in remission" as opposed to "cured" because the underlying medical problems which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical. This pilot study is a small clinical trial to test the feasibility and acceptability of a home-based exercise regimen. The investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving lower extremity strength, lower extremity tissue perfusion and glycemic control.

Detailed description

Population: 25 Veterans with a healed foot ulcer in the last 3-15 months Site: VA Maryland Health Care System (VAMHCS) Study Duration: Approximately 2 years Study Design: Randomized, outcome assessor blinded, clinical trial comparing a) a 12-week home-based exercise regimen to b) standard of care Objectives: Primary: To assess the feasibility and acceptability of the intervention. Secondary: * The effect of the intervention on gait speed, * The effect of the intervention on other measures of mobility and function including six-minute walk distance, the Modified Physical Performance Test, steps per day and community mobility, and * The effect of the intervention on lower extremity strength, perfusion of the foot and glycemic control. Treatment Regimens: 12-week home-based exercise regimen to standard of care Duration of Participant's Participation: Up to 31 weeks

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
BEHAVIORAL	12-week home based exercise	Consistent with current physical activity recommendations for older adults, participants randomized in this arm will be prescribed 5 days/week of exercise, with seated cycling exercise performed on 3 days a week (Monday, Wednesday and Friday), and strength/balance exercise performed 2 days a week (Tuesday and Thursday).
BEHAVIORAL	12-week standard of care	Participants in this group will be provided with guidance on the current standard of care. This includes guidance that these patients should slowly increase ambulation with appropriately fitted footwear.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-06-30
• Completion: 2027-03-31
• First posted: 2024-03-15
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States