Tailored lifestyle intervention for diabetic foot ulcer care
Official title: Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers
Run by University of Southern California · NCT06278935 · Data updated 2026-11-12
This study is testing a new online program led by occupational therapists to help people with diabetic foot ulcers better manage their care and follow treatment plans over 8 weeks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | February 10, 2025 |
| Main results expected | April 2026 |
| Study ends | April 2026 |
| Registry record updated | May 18, 2025 |
| Trial ID | NCT06278935 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking adults aged 21 and older with a history of active diabetic foot ulcers requiring offloading treatment.
✕Probably not a fit
Patients who are deaf or blind, or those with a history of lower extremity amputation beyond the toes 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 pilot clinical trial aims to develop and test a tailored, occupational therapist-led lifestyle intervention to improve care for patients with diabetic foot ulcers (DFUs). Participants will receive a self-management intervention focused on offloading treatment over a period of up to 8 weeks, delivered virtually. The study will assess the acceptability and feasibility of this approach through pre/post surveys and interviews with participants and care team members. The goal is to enhance adherence to offloading treatments, which are crucial for healing DFUs.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the management and healing of diabetic foot ulcers, reducing the risk of complications such as amputation.
How similar studies have gone: While the approach is innovative, similar lifestyle-focused interventions have shown promise in improving patient outcomes in other chronic conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * English speaking * Age 21 years or older * History of active DFU necessitating offloading * Capacity to provide informed consent * Access to telehealth (internet connection and equipment) * Ability to walk independently or with an assistive device * Self-reported life expectancy of more than one year Exclusion Criteria: * Self-reported deafness or blindness * history of lower extremity amputation besides toes
Where it's running
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University of Southern California
Los Angeles, California, United States Recruiting
Study contacts
- Study coordinator: Tze Woei Tan
- Email: tze-woei.tan@med.usc.edu
- Phone: 3234426835
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.