On the Move: Center and Home-Based Exercise to Enhance Mobility in Diabetic Foot Ulcer Recovery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 12-week exercise regimen, 12-week standard of care.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcer. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- 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. - 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.
Primary outcome measures
- 6-minute walk distance [Time frame: 12 weeks]
Secondary outcome measures (9)
- Acceptability and Feasibility [Time frame: 12 weeks]
- Adherence to the exercise regimen [Time frame: 12 weeks]
- SmartMat metrics [Time frame: 12 weeks]
- Community Mobility [Time frame: 12 weeks]
- Mobility Function [Time frame: 12 weeks]
- Physical Activity [Time frame: 12 weeks]
- Muscular strength [Time frame: 12 weeks]
- Perfusion [Time frame: 12 weeks]
- Glycemic Control [Time frame: 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06894563 · HP-00113990