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Diabetic Foot UlcerNCT06312579

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

A study testing 12-week home based exercise in people with Diabetic Foot Ulcer, run by VA Office of Research and Development at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Diabetic Foot Ulcer
What is being tested?
12-week home based exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteUnited States
Study dates
1 Oct 2024to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

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

    Baltimore, Maryland, 21201

Other trials in United States

About this study

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

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.

Read the 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 31 weeks

Being tested
12-week home based exercise, 12-week standard of care
Keywords
Clinical trial, Mobility, Diabetic foot ulcer
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 12-week home based exerciseBehavioural

    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 careBehavioural

    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.

Study groups in NCT06312579
Study groupRoleWhat they receive
12-week home based exerciseExperimentalConsistent 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).
Receives: Behavioral: 12-week home based exercise
12-week standard of carePlacebo comparatorParticipants 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.
Receives: Behavioral: 12-week standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12-weeks

Secondary outcomes (11)

  1. 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.

    Measured: 12-weeks

  2. Physical Activity

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

    Measured: 12-weeks

  3. 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)

    Measured: 12-weeks

  4. Muscular strength

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

    Measured: 12-weeks

  5. Perfusion

    Cutaneous perfusion will be assessed on the dorsal and plantar surfaces of the foot using laser Doppler flowmetry using the PeriFlux System 5000

    Measured: 12-weeks

  6. Glycemic control

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

    Measured: 12-weeks

  7. Mobility

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

    Measured: 12-weeks

  8. Acceptability

    Acceptability will be measured through a semi-structured interview.

    Measured: 12-weeks

  9. 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.

    Measured: 12-weeks

  10. 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.

    Measured: 12-weeks

  11. Community mobility

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

    Measured: 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start1 Oct 2024
  3. Primary completion30 Jun 2026
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06312579
Sponsor's protocol ID
E4897-P
Status last verified
Aug 2026
First submitted
28 Feb 2024
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Final data sets underlying all publications resulting from the proposed research will be shared outside VA. A limited dataset will be created and shared pursuant to a Data Use Agreement. Final data sets will be maintained locally until enterprise-level resources become available. Upon request, we will provide an electronic limited dataset to others in the scientific community with the implementation of appropriate data use agreements.

Publications

  • Robinson GL, Drumheller J, Lydecker AD, Rammling B, Dennis EA, Addison O, Prior SJ, Beamer BA, Sorkin JD, Gottlieb HD, Trent K, Roghmann MC. Home-Based Exercise to Improve Functional Outcomes in Veterans With a Recently Healed Diabetic Foot Ulcer: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 23;14:e71237. doi: 10.2196/71237.

    PubMed 40986852

Questions about this trial

What is this clinical trial studying?

A study testing 12-week home based exercise in people with Diabetic Foot Ulcer, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait speed (time frame: 12-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06312579, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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