Clinical trial Recruiting at 2 sites Interventional Ages 21 and up

Lifestyle intervention to prevent diabetic foot ulcers from coming back

Official title: Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study

Run by University of Southern California · NCT06487780 · Data updated 2026-11-12

This study tests a lifestyle program to help people who have healed diabetic foot ulcers take better care of their feet and manage their diabetes to prevent the ulcers from coming back.

Quick facts

Study typeInterventional
Ages21 Years and up
SexAll
Enrollment60 (estimated)
SponsorUniversity of Southern California
Academic / other
Locations3 sites (Downey, California and 2 other locations)
StatusRecruiting
StartedJune 11, 2025
Main results expectedJune 1, 2026
Study endsJune 30, 2026
Registry record updatedJune 22, 2025
Trial IDNCT06487780 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 21 and older who have healed from a diabetic foot ulcer within the past year and can walk independently.

Probably not a fit

Patients with current active diabetic foot ulcers or those who are non-ambulatory may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a lifestyle-focused program designed to help individuals with a history of healed diabetic foot ulcers (DFUs) maintain daily routines that promote foot care and diabetes management. The intervention, led by trained occupational therapists, aims to improve adherence to wearing special footwear and managing glucose levels to prevent the recurrence of DFUs. By addressing non-medical factors that hinder treatment adherence, the study seeks to enhance the quality of life for participants and reduce the risk of serious complications such as amputations.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the recurrence of diabetic foot ulcers, improving patients' mobility and quality of life.

How similar studies have gone: While lifestyle interventions for chronic conditions have shown promise, this specific approach targeting diabetic foot ulcer recurrence is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age \>= 21 years
* Healed diabetic foot ulcer within the past twelve months
* Able to walk independently (use of a cane is acceptable)

Exclusion Criteria:

* Current active diabetic foot ulcer
* History of amputation beside toe or part of the foot
* Non-ambulatory at baseline
* Self-reported deafness/blindness.

Where it's running

  • Keck Hospital of USC
    Los Angeles, California, United States
    Recruiting
  • Los Angeles General Medical Center
    Los Angeles, California, United States
    Recruiting
  • Rancho Los Amigos National Rehabilitation Center
    Downey, California, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.