Lifestyle Tailored Offloading for Diabetic Foot Ulcers

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06278935
Study type	Interventional
Source	University of Southern California
Contact	Tze Woei Tan
Phone	3234426835
Email	tze-woei.tan@med.usc.edu
Status	Not yet recruiting
Phase	N/A
Start date	April 2024
Completion date	April 2026

View Details

See also
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