On the Move: Center and Home-Based Exercise to Enhance Mobility in Diabetic Foot Ulcer Recovery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Behavioral: 12-week standard of care; Behavioral: 12-week exercise regimen

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)
• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Behavioral: 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.
Experimental: 12-week exercise regimen; 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.	Behavioral: 12-week exercise regimen; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
Adherence to the exercise regimen	Adherence to the exercise regimen will be assessed using written logs of attendance to group exercise.	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.	12 weeks
Community Mobility	Community mobility will be assessed using the Life-Space Assessment (LSA).	12 weeks
Mobility Function	Mobility function will be assessed using the Modified Physical Performance Test (MPPT)	12 weeks
Physical Activity	Physical activity will be assessed as average steps per day, measured with a FitBit.	12 weeks
Muscular strength	Knee extension and plantar flexion strength will be assessed using a MicroFET 2 Handheld Dynamometer.	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.	12 weeks
Glycemic Control	Blood samples will be obtained by venipuncture for HbA1c measurement.	12 weeks

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: VA Office of Research and Development

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Diabetic foot ulcer; Clinical trial; Mobility
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Diabetic Foot; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: HP-00113990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: Implementation of appropriate data use agreements. Email the study PI, Dr. Mary-Claire Roghmann (mroghmann@som.umaryland.edu), to start the process.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No