Applying the ADAPT-ITT framework to adapt a lifestyle Redesign® occupational therapy intervention for diabetic foot ulcer self-management.
Stacey L Schepens Niemiec, Lauren Styer, Jasmine Chapman...
https://pubmed.ncbi.nlm.nih.gov/42228560/Actively Recruiting
Led by University of Southern California · Updated on 2025-05-18
20
Participants Needed
1
Research Sites
N/A
Total Duration
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
Adapting Lifestyle Offloading for DFUs
T
Tze Woei Tan
J
Jason Garcia
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University of Southern California
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | OT‑delivered lifestyle offloading sessions (trial) | Guideline‑recommended offloading (current care) |
|---|---|---|
| What this is | A virtual lifestyle‑focused program delivered by an occupational therapist over up to eight sessions (~8 weeks) to support offloading self‑management for people with diabetic foot ulcers. | A non‑removable knee‑high offloading device (total contact cast) is the guideline‑recommended first‑choice method to relieve pressure and promote healing of diabetic foot ulcers. |
| Role in study | Investigational intervention tested in a single‑arm design. | Not included in the trial; provided for clinical context only. |
| Primary purpose | To help participants adopt lifestyle and behavioral strategies for offloading and managing diabetic foot ulcers. | To mechanically offload pressure from foot ulcers and facilitate healing. |
| How it is administered or performed | Delivered virtually by an occupational therapist in up to eight weekly sessions (~8 weeks). | Applied as a non‑removable knee‑high cast molded to offload ulcer‑bearing areas. |
| Evidence maturity | Effectiveness is currently being evaluated in this trial; evidence not yet established. | High‑quality evidence and international guideline backing demonstrate effectiveness in healing diabetic foot ulcers. |
| Important risks | Behavioral intervention likely low physical risk, but safety profile not yet reported. | Non‑removable casts may have risks such as skin breakdown or cast tolerance issues. |
| Important limitations | No control group; behavioral delivery limits ability to compare directly with device‑based offloading. | Casts may limit mobility or daily activities and require clinic visits for fitting. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Stacey L Schepens Niemiec, Lauren Styer, Jasmine Chapman...
https://pubmed.ncbi.nlm.nih.gov/42228560/University of Southern California
Lead Sponsor