On the Move: Center and Home-Based Exercise to Enhance Mobility in Diabetic Foot Ulcer Recovery
A legfontosabb adatok
- Ki végzi
- University of Maryland, Baltimore
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 60 fő, tervezett
- Kezdés
- 2027. jún.
- Várható befejezés
- 2029. dec.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- 12-week exercise regimen
- 12-week standard of care
- A regiszteradat frissítve
- 2026. október 7.
Ki vehet részt
- Életkor
- 50 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- 12-week exercise regimenA vizsgált kezelés
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, összehasonlításként
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.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2026. október 7.