Actively Recruiting
Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers
Led by University of Southern California · Updated on 2025-05-18
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Diabetic foot ulcers (DFUs) are common and can lead to serious complications like major amputation and death. This research aims to develop and test a lifestyle-focused intervention led by occupational therapists to help patients better manage their DFU care. The study primarily seeks to determine if this tailored approach is acceptable and feasible for patients who need offloading treatment as part of comprehensive DFU management. Participants with DFUs requiring offloading treatment will receive up to eight virtual lifestyle-based self-management sessions with a licensed occupational therapist over about eight weeks. This intervention will be co-developed with input from patients, caregivers, family members, and the DFU care team. At the end of the intervention, focus group interviews will be conducted with care team members and therapists to gather feedback on acceptability and feasibility. During the study, participants will complete surveys before and after the intervention to measure patient satisfaction, diabetes distress, and knowledge about offloading. Some will also participate in interviews to discuss their experiences with the intervention. Researchers will monitor DFU-related outcomes for six months after enrollment. Participation involves telemedicine sessions and follow-up assessments, with total intervention lasting approximately eight weeks.
CONDITIONS
Brief Title
Adapting Lifestyle Offloading for DFUs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English speaking
- Age 21 years or older
- History of active diabetic foot ulcer 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
You will not qualify if you...
- Self-reported deafness or blindness
- History of lower extremity amputation besides toes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (virtual)
Duration - Up to 8 weeks
Participants receive lifestyle-based treatment sessions virtually with a licensed occupational therapist to help manage diabetic foot ulcers.
Up to 8 virtual treatment sessions
Duration - 6 months
Participants are monitored for diabetic foot ulcer-related outcomes after completing the intervention.
Follow-up assessments post-enrollment
Trial Site Locations
Total: 1 location
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
Research Team
T
Tze Woei Tan
J
Jason Garcia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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