At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers

VA Office of Research and Development

Status: Invitation-only

Conditions: Diabetic Foot Ulcer

Treatments: Behavioral: 12-week standard of care; Behavioral: 12-week home based exercise

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06312579

E4897-P

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

12-week home based exercise

Experimental group

Description:

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).

Treatment:

Behavioral: 12-week home based exercise

12-week standard of care

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: 12-week standard of care