Adapting Lifestyle Offloading for DFUs

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT06278935
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lifestyle-based intervention by an occupational therapist — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 10, 2025
Status verified
May 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lifestyle-based intervention by an occupational therapist
    Participants with diabetic foot ulcers will be offered lifestyle-based treatment sessions over telemedicine for up to 8 sessions with a licensed occupational therapist.

Primary Outcome Measure

Patient satisfaction (change from baseline) [ Time Frame: Baseline and discharge from OT (3 to 8 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033
Tze-Woei Tan
[email protected]
323-442-6835
Stacey Schepens Niemiec, PhD
[email protected]
323-442-2069

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By research site
University of Southern California· Los Angeles, CA

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