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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 16 weeks ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06312579
Study type	Interventional
Source	VA Office of Research and Development
Contact	Frederick M Ivey, PhD
Phone	(410) 605-7000
Email	Frederick.Ivey@va.gov
Status	Not yet recruiting
Phase	Phase 2
Start date	October 1, 2024
Completion date	March 31, 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.