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 which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical. This pilot study is a small clinical trial to test the feasibility and acceptability of a home-based exercise regimen. The investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving lower extremity strength, lower extremity tissue perfusion and glycemic control.
Detailed description
Population: 25 Veterans with a healed foot ulcer in the last 3-15 months Site: VA Maryland Health Care System (VAMHCS) Study Duration: Approximately 2 years Study Design: Randomized, outcome assessor blinded, clinical trial comparing a) a 12-week home-based exercise regimen to b) standard of care Objectives: Primary: To assess the feasibility and acceptability of the intervention. Secondary: * The effect of the intervention on gait speed, * The effect of the intervention on other measures of mobility and function including six-minute walk distance, the Modified Physical Performance Test, steps per day and community mobility, and * The effect of the intervention on lower extremity strength, perfusion of the foot and glycemic control. Treatment Regimens: 12-week home-based exercise regimen to standard of care Duration of Participant's Participation: Up to 31 weeks
Interventions
BEHAVIORAL12-week home based exercise
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 (Monday, Wednesday and Friday), and strength/balance exercise performed 2 days a week (Tuesday and Thursday).
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
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 * Prior plantar foot ulcer or moderate-severe diabetic foot infection or minor lower extremity amputation. * 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 * Current plantar foot ulcer or pre-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 |
|---|---|---|
| Gait speed | 12-weeks | Usual gait speed will be calculated based on a 10-meter walk distance. The investigators will provide individuals with a 14-meter path for walking to provide room for a "flying start." The participant will walk 14 meters, but gait speed will only be timed during the intermediate 10 meters. This will allow us to determine gait speed without the confounding factor of acceleration and deceleration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility- Recruitment | 12-weeks | Acceptable recruitment will be assessed among those in the intervention. Acceptable recruitment is defined as 90% of targeted enrollment within 15 months of initiating recruitment efforts. |
| Physical Activity | 12-weeks | Physical activity will be assessed as average steps per day, measured with a FitBit. |
| Acceptability- Usage Rating Profile-Intervention | 12-weeks | Acceptability will be measured using the Usage Rating Profile-Intervention (URPI). A higher score indicates greater acceptability of the intervention. The URPI uses a 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree) |
| Muscular strength | 12-weeks | Knee extension and plantar flexion strength will be assessed using a MicroFET 2 Hand-held 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 of a vein in the upper extremity for HbA1c measurement. |
| Mobility | 12-weeks | Community mobility will be assessed using the Life-Space Assessment (LSA). |
| Acceptability | 12-weeks | Acceptability will be measured through a semi-structured interview. |
| Adherence to the exercise regimen | 12-weeks | Adherence to the exercise regimen will be assessed using written logs of home-based exercise, attendance to virtual group exercise, and anonymized FitBit accounts. |
| Feasibility- Retention | 12-weeks | Retention will be assessed among those in the intervention. Acceptable retention will be assessed by 80% participation in exercise intervention and study visits. |
| Community mobility | 12-weeks | Community mobility will be assessed using the Life-Space Assessment (LSA). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMary-Claire Roghmann, MD
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Outcome results
None listed