Clinical trial NCT06278935: Adapting Lifestyle Offloading for DFUs
Official title: Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Diabetic Foot
Keywords: Offloading diabetic foot ulcer
Lifestyle-focused intervention
Occupational therapy
Occupational therapist
Self management
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction (change from baseline)
timeFrame: Baseline and discharge from OT (3 to 8 weeks)
Secondary outcomes:
measure: Diabetes distress (change from baseline)
timeFrame: Baseline and discharge from OT (3 to 8 weeks)
measure: Offloading knowledge and attitudes (change from baseline)
timeFrame: Baseline and discharge from OT (3 to 8 weeks)
measure: Frequency of DFU-related outcomes
timeFrame: 6-month post-enrollment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References: