Clinical trial NCT06312579: At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers
Official title: Home-based Exercise to Improve Functional Outcomes in Veterans With Recently Healed Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Keywords: Clinical trial
Mobility
Diabetic foot ulcer
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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

Eligibility criteria: 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

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

Primary outcomes:
measure: Gait speed
timeFrame: 12-weeks
Secondary outcomes:
measure: Feasibility- Recruitment
timeFrame: 12-weeks
measure: Physical Activity
timeFrame: 12-weeks
measure: Acceptability- Usage Rating Profile-Intervention
timeFrame: 12-weeks
measure: Muscular strength
timeFrame: 12-weeks
measure: Perfusion
timeFrame: 12-weeks
measure: Glycemic control
timeFrame: 12-weeks
measure: Mobility
timeFrame: 12-weeks
measure: Acceptability
timeFrame: 12-weeks
measure: Adherence to the exercise regimen
timeFrame: 12-weeks
measure: Feasibility- Retention
timeFrame: 12-weeks
measure: Community mobility
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Mary-Claire Roghmann, MD
role: PRINCIPAL_INVESTIGATOR
References: