NCT Number: NCT06894563
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.
Trial opening soon.
Get Notified50 year and older
All sexes
Interventional
Not applicable
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 12 weeks
Using standard procedures participants will be asked to walk as far as possible in 6 minutes along a 100-foot course. Primary clinical outcome is total distance covered.
Time frame: 12 weeks
Acceptability and feasibility of the intervention by the participant will be measured using the Usage Rating Profile-Intervention (URPI) at each phase or transition of the intervention and through a semi-structured interview.
Time frame: 12 weeks
Adherence to the exercise regimen will be assessed using written logs of attendance to group exercise.
Time frame: 12 weeks
Use of SmartMat to measure the temperature of the plantar aspect of the foot and triggers (sustained asymmetric increase in temperature) for a potential foot complication.
Time frame: 12 weeks
Community mobility will be assessed using the Life-Space Assessment (LSA).
Time frame: 12 weeks
Mobility function will be assessed using the Modified Physical Performance Test (MPPT)
Time frame: 12 weeks
Physical activity will be assessed as average steps per day, measured with a FitBit.
Time frame: 12 weeks
Knee extension and plantar flexion strength will be assessed using a MicroFET 2 Handheld Dynamometer.
Time frame: 12 weeks
Cutaneous perfusion will be assessed on the dorsal and plantar surfaces of the foot using laser Doppler flowmetry using the PeriFlux System 5000.
Time frame: 12 weeks
Blood samples will be obtained by venipuncture for HbA1c measurement.
University of Maryland, Baltimore
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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