Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

University of Maryland, Baltimore

Collaborating Sponsors:

VA Office of Research and Development

Conditions:

Diabetic Foot Ulcer

Eligibility:

All Genders

50+ years

Phase:

NA

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 wit...

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 assess...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2028

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06894563

Start Date

June 1 2026

End Date

December 1 2028

Last Update

September 9 2025

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