Lifestyle Intervention for Diabetic Foot Ulcers

Overseen By Jason Garcia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Deafness, Blindness, Amputation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 3 to 8 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention.

Eligibility Criteria

This trial is for adults over 21 who speak English or Spanish and have an active diabetic foot ulcer (DFU) that requires offloading, which means reducing pressure on the foot to help healing.

Inclusion Criteria

I have had a diabetic foot ulcer that required special footwear or a cast.

I am 21 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lifestyle-based treatment sessions virtually with a licensed occupational therapist

3 to 8 weeks

Up to 8 sessions (virtual)

Follow-up

Participants are monitored for DFU-related outcomes including healing, amputation, and ulcer recurrence

6 months

Treatment Details

Interventions

• Lifestyle-based intervention

Trial Overview The study tests a new way to manage DFUs with a lifestyle-based intervention led by an occupational therapist. It's designed to see if this personalized approach helps patients better care for their ulcers.

Participant Groups

Group I: Lifestyle-based intervention by an occupational therapist Experimental Treatment 1 Intervention

Participants with diabetic foot ulcers will be offered lifestyle-based treatment sessions over telemedicine for up to 8 sessions with a licensed occupational therapist.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+