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

NCT06312579 | Active Not Recruiting DMC

• 1 other identifier: E4897-P
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetic Foot Ulcer

Keywords

Clinical trial; Mobility; Diabetic foot ulcer

Outcome Measures

Primary Outcomes (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.

  12-weeks

Secondary Outcomes (11)

• Feasibility- Recruitment

  12-weeks

• Physical Activity

  12-weeks

• Acceptability- Usage Rating Profile-Intervention

  12-weeks

• Muscular strength

  12-weeks

• Perfusion

  12-weeks

Study Arms (2)

12-week home based exercise

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 (Monday, Wednesday and Friday), and strength/balance exercise performed 2 days a week (Tuesday and Thursday).

Behavioral: 12-week home based exercise

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 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 home based exercise

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
• 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

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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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.

  PMID: 40986852 DERIVED

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 Officials

• Mary-Claire Roghmann, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• 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: February 28, 2024
• First Posted: March 15, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The protocol and SAP will be made available before analysis
• Access Criteria: Implementation of appropriate data use agreements. Email the study PI, Dr. Mary-Claire Roghmann (mroghmann@som.umaryland.edu), to start the process.

Locations

US (1)