On the Move: Center and Home-Based Exercise to Enhance Mobility in Diabetic Foot Ulcer Recovery
Key facts
- Who runs it
- University of Maryland, Baltimore
- Trial code
- Status
- Not yet recruiting
- People taking part
- 60 people, planned
- Starts
- Jun 2027
- Expected to end
- Dec 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- 12-week exercise regimen
- 12-week standard of care
- Record updated
- 7 October 2026
Who can take part
- Age
- 50 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Anticipated foot surgery in the next 4 months
- Unable to perform the exercise interventions (e.g. due to hearing or visual impairment)
- Severe peripheral arterial disease (Fontaine stage 3 rest pain or 4 ischemic ulcers/gangrene)
- Current plantar foot ulcer
- Participating in another exercise program
- Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate safely
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- 12-week exercise regimenTreatment being tested
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 carePlacebo, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 7 October 2026