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Active Not Recruiting NCT06312579

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

Conditions: Diabetic Foot Ulcer

Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 26
Sponsor: VA Office of Research and Development

Location: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Baltimore Maryland

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06312579). StuddyBuddy aggregates publicly available trial information.