NCT06312579

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

Active, enrolled NA Last updated 8 April 2026

What this trial tests

NA trial testing 12-week home based exercise in Diabetic Foot Ulcer in 26 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 October 2024

Primary endpoint
30 June 2026

31 March 2027

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	26
Start date	1 October 2024
Primary completion	30 June 2026
Estimated completion	31 March 2027
Sites	1 location across United States

Drugs / interventions tested

• 12-week home based exercise
• 12-week standard of care

Conditions studied

• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

50 and older, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Home-Based Exercise to Improve Functional Outcomes in Veterans With a Recently Healed Diabetic Foot Ulcer: Protocol for a Pilot Randomized Controlled Trial.
   Robinson GL, Drumheller J, Lydecker AD, Rammling B, et al · · 2025 · PMID 40986852 · DOI 10.2196/71237