protocolSection identificationModule nctId: NCT06312579, orgStudyIdInfo id: E4897-P, briefTitle: At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: 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., conditionsModule conditions: Diabetic Foot Ulcer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a single center, randomized, outcome assessor blinded, parallel group clinical trial comparing a 12-week exercise regimen to standard of care., primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: 12-week home based exercise, interventions name: 12-week standard of care, outcomesModule primaryOutcomes measure: Gait speed, secondaryOutcomes measure: Feasibility- Recruitment, secondaryOutcomes measure: Physical Activity, secondaryOutcomes measure: Acceptability- Usage Rating Profile-Intervention, secondaryOutcomes measure: Muscular strength, secondaryOutcomes measure: Perfusion, secondaryOutcomes measure: Glycemic control, secondaryOutcomes measure: Mobility, secondaryOutcomes measure: Acceptability, secondaryOutcomes measure: Adherence to the exercise regimen, secondaryOutcomes measure: Feasibility- Retention, secondaryOutcomes measure: Community mobility, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, city: Baltimore, state: Maryland, zip: 21201, country: United States, contacts name: Frederick M Ivey, PhD, role: CONTACT, phone: 410-605-7000, phoneExt: 56510, email: Frederick.Ivey@va.gov, contacts name: Mary-Claire Roghmann, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False