NCT06278935

Adapting Lifestyle Offloading for DFUs

Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Diabetic foot ulcers (DFUs) frequently lead to major amputation and mortality. While relieving foot pressure (i.e., offloading) is vital for healing, many patients struggle to adhere to recommended offloading treatments. Participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention. This occupational therapist-led lifestyle-focused intervention will be co-developed with participants, caregivers, family members, and DFU care team members. Participants with DFUs will be offered lifestyle-based treatment sessions for up to 8 weeks (virtually) with a licensed occupational therapist. Participants will complete pre/post surveys and a subset will take part in an interview to clarify key findings from surveys and obtain patients' perspective of the effectiveness of the intervention. Investigators will also offer focus group interviews to the DFU care team members and occupational therapist to learn their perceptions on the intervention's acceptability, appropriateness, efficiency, and feasibility at the conclusion of the intervention.

Conditions

• Diabetic Foot Ulcer
• Diabetic Foot

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle-based intervention by an occupational therapist	Participants with diabetic foot ulcers will be offered lifestyle-based treatment sessions virtually for up to 8 sessions (\~8 weeks) with a licensed occupational therapist.

Timeline

• Start date: 2025-02-10
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-02-26
• Last updated: 2025-05-18

Locations

1 site across 1 country: United States