Diabetic Foot Ulcer
Conditions
Keywords
Clinical trial, Mobility, Diabetic foot ulcer
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
Interventions
BEHAVIORAL12-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.
BEHAVIORAL12-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.
Sponsors
VA Office of Research and Development
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk distance | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the exercise regimen | 12 weeks | Adherence to the exercise regimen will be assessed using written logs of attendance to group exercise. |
| SmartMat metrics | 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. |
| Community Mobility | 12 weeks | Community mobility will be assessed using the Life-Space Assessment (LSA). |
| Mobility Function | 12 weeks | Mobility function will be assessed using the Modified Physical Performance Test (MPPT) |
| Acceptability and Feasibility | 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. |
| Muscular strength | 12 weeks | Knee extension and plantar flexion strength will be assessed using a MicroFET 2 Handheld Dynamometer. |
| Perfusion | 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. |
| Glycemic Control | 12 weeks | Blood samples will be obtained by venipuncture for HbA1c measurement. |
| Physical Activity | 12 weeks | Physical activity will be assessed as average steps per day, measured with a FitBit. |
Outcome results
None listed