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

Running, not enrolling · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT06312579

Run by

VA Office of Research and Development

People needed

26

Starts

2024-10-01

Expected to finish

2027-03-31

Last updated by the study team

2026-04-21

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults >= 50 years
• Diagnosis of diabetes
• Prior plantar foot ulcer or moderate-severe diabetic foot infection or minor lower extremity amputation.
• Two feet (can have healed minor amputations of fore and midfoot)
• Willing to wear appropriately fitted footwear for exercise regimen
• Ambulatory without walker
• Willing to enroll in the PODIMETRICS SmartMat program
• Able to give written informed consent

You may not qualify if…

• Unable to perform the exercise interventions (e.g. due to hearing or visual impairment)
• Anticipated foot surgery in the next 4 months
• Participating in another exercise program
• Current plantar foot ulcer or pre-ulcer
• Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate safely

Where it is running

• Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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