| Registry | NCT06894563 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 60 (Estimated) |
| Sponsor | University of Maryland, Baltimore (Other); collaborators: VA Office of Research and Development |
| Conditions | Diabetic Foot Ulcer |
| Interventions | 12-week exercise regimen, 12-week standard of care (Behavioral) |
| Dates | start 2027-06-01 (estimated), primary completion 2029-06-01 (estimated), completion 2029-12-01 (estimated), first posted 2025-03-25, last updated 2026-10-07 |
Related Papers Related Patents Related Grants Related Experts
All trials for Diabetic Foot Ulcer All trials of 12-week exercise regimen All trials of 12-week standard of care
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 (e.g., peripheral neuropathy, peripheral arterial disease) which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation with appropriate footwear so as not to promote ulcer recurrence. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical, as immobility is the leading cause of nursing home admissions.
This is a clinical trial to test the feasibility and acceptability of an exercise regimen that transitions from in-person to home-based. The investigators will also assess if this exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving mobility, lower extremity strength, lower extremity tissue perfusion and glycemic control.
Population: 60 Veterans with a healed foot ulcer in the last 3-15 months
Site: VA Maryland Health Care System (VAMHCS)
Study Duration: Approximately 3 years
Study Design: Randomized, outcome assessor blinded, clinical trial comparing a) a 12-week exercise regimen to b) standard of care
Objectives:
Primary: To assess the feasibility and acceptability of the intervention and estimate the effect of the intervention on 6-minute walk distance.
Secondary:
The effect of the intervention on other measures of mobility and function including gait speed, the Modified Physical Performance Test, steps per day and community mobility following the 12-week intervention and 6-months after to assess retention of the intervention.
The effect of the intervention on lower extremity strength, perfusion of the foot and glycemic control.
Treatment Regimens: 12-week exercise regimen to standard of care
Duration of Participant's Participation: Up to 10 months
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 12-week exercise regimen | Experimental | Behavioral: 12-week exercise regimen | Consistent with current physical activity recommendations for older adults, participants randomized in this arm will be prescribed 5 days/week of exercise, with seated cycling exercise performed on 3 days a week and strength/balance exercise performed 2 days a week. |
| 12-week standard of care | Placebo comparator | Behavioral: 12-week standard of care | Participants in this group will be provided with guidance on the current standard of care. This includes guidance that these patients should slowly increase ambulation with appropriately fitted footwear. |
Sex: All, ages: 50 Years to any
Inclusion Criteria: * Adults >= 50 years * Diagnosis of diabetes * Plantar foot ulcer which healed within the last 3-15 months * 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 * Severe peripheral arterial disease (Fontaine stage 3 rest pain or 4 ischemic ulcers/gangrene) * Current plantar foot ulcer * Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate safely