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

Phase 2

• Conditions: Diabetic Foot Ulcer
• Interventions: Behavioral: 12-week standard of care; Behavioral: 12-week home based exercise

• Registration Number: NCT06312579
• Lead Sponsor: VA Office of Research and Development

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 16 weeks

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Status Verified: 2024-10
• Study Start: 2024-10-01
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adults >= 50 years
• Diagnosis of diabetes
• Plantar foot ulcer which healed within the last 3-27 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12-week standard of care	12-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.
12-week home based exercise	12-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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Muscular strength	12-weeks	Knee extension and plantar flexion strength will be assessed using a MicroFET 2 Hand-held Dynamometer
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.
Glycemic control	12-weeks	Blood samples will be obtained by venipuncture of a vein in the upper extremity for HbA1c measurement.
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)
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.
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.
Community mobility	12-weeks	Community mobility will be assessed using the Life-Space Assessment (LSA).

Trial Locations

Locations (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD; 🇺🇸 Baltimore, Maryland, United States