Clinical trial Recruiting at 1 site Interventional Ages 21 and up

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.

More Diabetic Foot trials

Quick facts

Study typeInterventional
Ages21 Years and up
SexAll
Enrollment20 (estimated)
SponsorUniversity of Southern California
Academic / other
Locations1 site (Los Angeles, California)
StatusRecruiting
StartedFebruary 10, 2025
Main results expectedApril 2026
Study endsApril 2026
Registry record updatedMay 18, 2025
Trial IDNCT06278935 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

  • University of Southern California
    Los Angeles, California, United States
    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.