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Active, Not Recruiting

NCT Number: NCT06312579

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

12-week home based exercise

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Gait speed

    Time frame: 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 outcomes

  1. Feasibility- Recruitment

    Time frame: 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.

  2. Physical Activity

    Time frame: 12-weeks

    Physical activity will be assessed as average steps per day, measured with a FitBit.

  3. Acceptability- Usage Rating Profile-Intervention

    Time frame: 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)

  4. Muscular strength

    Time frame: 12-weeks

    Knee extension and plantar flexion strength will be assessed using a MicroFET 2 Hand-held Dynamometer

  5. Perfusion

    Time frame: 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

  6. Glycemic control

    Time frame: 12-weeks

    Blood samples will be obtained by venipuncture of a vein in the upper extremity for HbA1c measurement.

  7. Mobility

    Time frame: 12-weeks

    Community mobility will be assessed using the Life-Space Assessment (LSA).

  8. Acceptability

    Time frame: 12-weeks

    Acceptability will be measured through a semi-structured interview.

  9. Adherence to the exercise regimen

    Time frame: 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.

  10. Feasibility- Retention

    Time frame: 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.

  11. Community mobility

    Time frame: 12-weeks

    Community mobility will be assessed using the Life-Space Assessment (LSA).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 15, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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