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

Diabetic Foot Ulcer Clinical Trial

Official title:

Home-based Exercise to Improve Functional Outcomes in Veterans With Recently Healed Diabetic Foot Ulcer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06312579
• Other study ID #: E4897-P
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: Frederick M Ivey, PhD
• Phone: (410) 605-7000
• Email: Frederick.Ivey[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)
• Appropriately fitted footwear for exercise regimen
• Ambulatory without front wheel walker
• Enrolled 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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Behavioral:
• 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).
• 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.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed	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.	12-weeks
Secondary	Feasibility- Recruitment	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.	12-weeks
Secondary	Physical Activity	Physical activity will be assessed as average steps per day, measured with a FitBit.	12-weeks
Secondary	Acceptability- Usage Rating Profile-Intervention	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)	12-weeks
Secondary	Muscular strength	Knee extension and plantar flexion strength will be assessed using a MicroFET 2 Hand-held Dynamometer	12-weeks
Secondary	Perfusion	Cutaneous perfusion will be assessed on the dorsal and plantar surfaces of the foot using laser Doppler flowmetry using the PeriFlux System 5000	12-weeks
Secondary	Glycemic control	Blood samples will be obtained by venipuncture of a vein in the upper extremity for HbA1c measurement.	12-weeks
Secondary	Mobility	Community mobility will be assessed using the Life-Space Assessment (LSA).	12-weeks
Secondary	Acceptability	Acceptability will be measured through a semi-structured interview.	12-weeks
Secondary	Adherence to the exercise regimen	Adherence to the exercise regimen will be assessed using written logs of home-based exercise, attendance to virtual group exercise, and anonymized FitBit accounts.	12-weeks
Secondary	Feasibility- Retention	Retention will be assessed among those in the intervention. Acceptable retention will be assessed by 80% participation in exercise intervention and study visits.	12-weeks
Secondary	Community mobility	Community mobility will be assessed using the Life-Space Assessment (LSA).	12-weeks