Tailored lifestyle intervention for diabetic foot ulcer care
Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06278935 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 21 and older with a history of active diabetic foot ulcers requiring offloading treatment.
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.
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 performed: While the approach is innovative, similar lifestyle-focused interventions have shown promise in improving patient outcomes in other chronic conditions.
Eligibility criteria
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 this trial is running
Los Angeles, California
- 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
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.