Clinical trial NCT06894563: On the Move: Center and Home-Based Exercise to Enhance Mobility in Diabetic Foot Ulcer Recovery
Official title: On the Move: Center and Home-Based Exercise to Enhance Mobility in Diabetic Foot Ulcer Recovery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Clinical trial
Mobility
Diabetic foot ulcer
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: VA Office of Research and Development
First posted: 2025-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single center, randomized, outcome assessor blinded, parallel group clinical trial comparing a 12-week exercise regimen to standard of care.
Primary purpose: SUPPORTIVE_CARE

Brief 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 (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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: 6-minute walk distance
timeFrame: 12 weeks
Secondary outcomes:
measure: Acceptability and Feasibility
timeFrame: 12 weeks
measure: Adherence to the exercise regimen
timeFrame: 12 weeks
measure: SmartMat metrics
timeFrame: 12 weeks
measure: Community Mobility
timeFrame: 12 weeks
measure: Mobility Function
timeFrame: 12 weeks
measure: Physical Activity
timeFrame: 12 weeks
measure: Muscular strength
timeFrame: 12 weeks
measure: Perfusion
timeFrame: 12 weeks
measure: Glycemic Control
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: