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

NCT06894563 | Not Yet Recruiting DMC

• 1 other identifier: HP-00113990
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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 (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.

Conditions

Diabetic Foot Ulcer

Keywords

Clinical trial; Mobility; Diabetic foot ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Acceptability and Feasibility

  12 weeks

• Adherence to the exercise regimen

  12 weeks

• SmartMat metrics

  12 weeks

• Community Mobility

  12 weeks

• Mobility Function

  12 weeks

Study Arms (2)

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.

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.

Behavioral: 12-week standard of care

Interventions

12-week exercise regimen 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, and strength/balance exercise performed 2 days a week.

12-week exercise regimen

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.

12-week standard of care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• VA Office of Research and Development: collaborator

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center, randomized, outcome assessor blinded, parallel group clinical trial comparing a 12-week exercise regimen to standard of care.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 25, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Implementation of appropriate data use agreements. Email the study PI, Dr. Mary-Claire Roghmann (mroghmann@som.umaryland.edu), to start the process.