Adapting Lifestyle Offloading for DFUs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lifestyle-based intervention by an occupational therapist.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcer, Diabetic Foot. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers
Overview
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Patient satisfaction (change from baseline) [Time frame: Baseline and discharge from OT (3 to 8 weeks)]
Secondary outcome measures (3)
- Diabetes distress (change from baseline) [Time frame: Baseline and discharge from OT (3 to 8 weeks)]
- Offloading knowledge and attitudes (change from baseline) [Time frame: Baseline and discharge from OT (3 to 8 weeks)]
- Frequency of DFU-related outcomes [Time frame: 6-month post-enrollment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Southern California — Los Angeles
Publications
- Schepens Niemiec SL, Styer L, Chapman J, Myong E, Moshtael R, Lopez C, Arteaga J, Wong E, Motta Morales D, Kumar N, Tan TW. Applying the ADAPT-ITT framework to adapt a lifestyle Redesign(R) occupational therapy intervention for diabetic foot ulcer self-management. Transl Behav Med. 2026 Jan 7;16(1):ibag030. doi: 10.1093/tbm/ibag030. PMID 42228560
Identifiers
NCT: NCT06278935 · APP-24-00887