Diabetic Foot UlcerNCT06894563
On the Move: Center and Home-Based Exercise to Enhance Mobility in Diabetic Foot Ulcer Recovery
A study testing 12-week exercise regimen in people with Diabetic Foot Ulcer, run by University of Maryland, Baltimore.
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 exercise regimen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2027to Dec 2029
- 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
- Plantar foot ulcer which healed within the last 3-15 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
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
- Severe peripheral arterial disease (Fontaine stage 3 rest pain or 4 ischemic ulcers/gangrene)
- Current plantar foot ulcer
- Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate safely
About this study
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 (e.g., peripheral neuropathy, peripheral arterial disease) which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation with appropriate footwear so as not to promote ulcer recurrence. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical, as immobility is the leading cause of nursing home admissions.
This is a clinical trial to test the feasibility and acceptability of an exercise regimen that transitions from in-person to home-based. The investigators will also assess if this exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving mobility, lower extremity strength, lower extremity tissue perfusion and glycemic control.
Read the detailed description
Population: 60 Veterans with a healed foot ulcer in the last 3-15 months
Site: VA Maryland Health Care System (VAMHCS)
Study Duration: Approximately 3 years
Study Design: Randomized, outcome assessor blinded, clinical trial comparing a) a 12-week exercise regimen to b) standard of care
Objectives:
Primary: To assess the feasibility and acceptability of the intervention and estimate the effect of the intervention on 6-minute walk distance.
Secondary:
The effect of the intervention on other measures of mobility and function including gait speed, the Modified Physical Performance Test, steps per day and community mobility following the 12-week intervention and 6-months after to assess retention of the intervention.
The effect of the intervention on lower extremity strength, perfusion of the foot and glycemic control.
Treatment Regimens: 12-week exercise regimen to standard of care
Duration of Participant's Participation: Up to 10 months
- Conditions
- Diabetic Foot Ulcer
- Being tested
- 12-week exercise regimen, 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 exercise regimenBehavioural
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, and strength/balance exercise performed 2 days a week.
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 group | Role | What they receive |
|---|---|---|
| 12-week exercise regimen | Experimental | 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 and strength/balance exercise performed 2 days a week. Receives: Behavioral: 12-week exercise regimen |
| 12-week standard of care | Placebo comparator | 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. Receives: Behavioral: 12-week standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance
Using standard procedures participants will be asked to walk as far as possible in 6 minutes along a 100-foot course. Primary clinical outcome is total distance covered.
Measured: 12 weeks
Secondary outcomes (9)
Acceptability and Feasibility
Acceptability and feasibility of the intervention by the participant will be measured using the Usage Rating Profile-Intervention (URPI) at each phase or transition of the intervention and through a semi-structured interview.
Measured: 12 weeks
Adherence to the exercise regimen
Adherence to the exercise regimen will be assessed using written logs of attendance to group exercise.
Measured: 12 weeks
SmartMat metrics
Use of SmartMat to measure the temperature of the plantar aspect of the foot and triggers (sustained asymmetric increase in temperature) for a potential foot complication.
Measured: 12 weeks
Community Mobility
Community mobility will be assessed using the Life-Space Assessment (LSA).
Measured: 12 weeks
Mobility Function
Mobility function will be assessed using the Modified Physical Performance Test (MPPT)
Measured: 12 weeks
Physical Activity
Physical activity will be assessed as average steps per day, measured with a FitBit.
Measured: 12 weeks
Muscular strength
Knee extension and plantar flexion strength will be assessed using a MicroFET 2 Handheld Dynamometer.
Measured: 12 weeks
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
Glycemic Control
Blood samples will be obtained by venipuncture for HbA1c measurement.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study startJun 2027 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894563
- Sponsor's protocol ID
- HP-00113990
- Status last verified
- Oct 2026
- First submitted
- 7 Mar 2025
- Last updated
- 7 Oct 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On the Move: Center and Home-Based Exercise to Enhance Mobility in Diabetic Foot Ulcer Recovery
- ClinicalTrials.gov ID
- NCT06894563
- Acronym / sponsor ID
- HP-00113990
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Clinical trial, Mobility, Diabetic foot ulcer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- Jun 2027 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (e.g., peripheral neuropathy, peripheral arterial disease) which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation with appropriate footwear so as not to promote ulcer recurrence. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical, as immobility is the leading cause of nursing home admissions.
This is a clinical trial to test the feasibility and acceptability of an exercise regimen that transitions from in-person to home-based. The investigators will also assess if this exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving mobility, lower extremity strength, lower extremity tissue perfusion and glycemic control.
Detailed description
Population: 60 Veterans with a healed foot ulcer in the last 3-15 months
Site: VA Maryland Health Care System (VAMHCS)
Study Duration: Approximately 3 years
Study Design: Randomized, outcome assessor blinded, clinical trial comparing a) a 12-week exercise regimen to b) standard of care
Objectives:
Primary: To assess the feasibility and acceptability of the intervention and estimate the effect of the intervention on 6-minute walk distance.
Secondary:
The effect of the intervention on other measures of mobility and function including gait speed, the Modified Physical Performance Test, steps per day and community mobility following the 12-week intervention and 6-months after to assess retention of the intervention.
The effect of the intervention on lower extremity strength, perfusion of the foot and glycemic control.
Treatment Regimens: 12-week exercise regimen to standard of care
Duration of Participant's Participation: Up to 10 months
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 12-week exercise regimen | Experimental | Behavioral: 12-week exercise regimenConsistent 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 and strength/balance exercise performed 2 days a week. |
| 12-week standard of care | Placebo comparator | Behavioral: 12-week standard of careParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
- Willing to wear appropriately fitted footwear for exercise regimen
Key exclusion criteria (6 listed)
- 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
- Severe peripheral arterial disease (Fontaine stage 3 rest pain or 4 ischemic ulcers/gangrene)
- Current plantar foot ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week exercise regimenConsistent 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, and strength/balance exercise performed 2 days a week. | Behavioural | 12-week exercise regimen |
| 12-week standard of careParticipants 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. | Behavioural | 12-week standard of care |
Primary outcome
6-minute walk distance
Time frame: 12 weeks
Using standard procedures participants will be asked to walk as far as possible in 6 minutes along a 100-foot course. Primary clinical outcome is total distance covered.
9 secondary outcomes
Acceptability and Feasibility
Time frame: 12 weeks
Adherence to the exercise regimen
Time frame: 12 weeks
SmartMat metrics
Time frame: 12 weeks
Community Mobility
Time frame: 12 weeks
Mobility Function
Time frame: 12 weeks
Physical Activity
Time frame: 12 weeks
Muscular strength
Time frame: 12 weeks
Perfusion
Time frame: 12 weeks
Glycemic Control
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week exercise regimen in people with Diabetic Foot Ulcer, run by University of Maryland, Baltimore.
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 6 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
6-minute walk distance (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.