Lifestyle intervention to prevent diabetic foot ulcers from coming back
Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 3 sites (Downey, California and 2 other locations) |
| Trial ID | NCT06487780 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with current active diabetic foot ulcers or those who are non-ambulatory may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Downey, California and 2 other locations
- Rancho Los Amigos National Rehabilitation Center — Downey, California, United States (Not_yet_recruiting)
- Keck Hospital of USC — Los Angeles, California, United States (Recruiting)
- Los Angeles General Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Tze Woei Tan — University of Southern California
- Study coordinator: Tze-Woei Tan, MD
- Email: tze-woei.tan@med.usc.edu
- Phone: 3234426835
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.