Adapting Lifestyle Offloading for DFUs

University of Southern California

Status: Enrolling

Conditions: Diabetic Foot; Diabetic Foot Ulcer

Treatments: Behavioral: Lifestyle-based intervention by an occupational therapist

Study type: Interventional

Funder types: Other

Identifiers

NCT06278935

APP-24-00887

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Lifestyle-based intervention by an occupational therapist

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle-based intervention by an occupational therapist