Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-02-10
2026-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* history of lower extremity amputation besides toes
21 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Responsible Party
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Tze-Woei Tan
Associate Professor of Clinical Surgery
Locations
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University of Southern California
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APP-24-00887
Identifier Type: -
Identifier Source: org_study_id
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