Adapting Lifestyle Offloading for Diabetic Foot Ulcers

This study is testing a new way to help people with diabetic foot ulcers (DFUs) manage their condition. It uses a lifestyle-based approach led by an occupational therapist, delivered virtually. The goal is to see if this approach is helpful and practical for patients. You might be able to join if you are 21 or older, speak English, have an active DFU that needs offloading (reducing pressure on your foot), can give consent, have internet access for virtual sessions, and can walk on your own or with a device. The study will measure how satisfied patients are with this new intervention. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is a pilot study aiming to develop and test a tailored intervention.
What's involved
You would participate in up to 8 virtual lifestyle-based treatment sessions with an occupational therapist over about 8 weeks. You will also complete surveys before and after the intervention, and some participants may have an interview.
Compensation
Not stated in the trial record.
Follow-up
Patient satisfaction will be measured at the start of the study and at discharge from occupational therapy (3 to 8 weeks).

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NCT06278935

Adapting Lifestyle Offloading for DFUs

Recruiting
NAAges 21+InterventionalTreatment
University of Southern California
~20 participants
Updated 2025-05-18 on ClinicalTrials.gov
What's tested:Lifestyle-based intervention by an occupational therapist

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient satisfaction (change from baseline)
Measured over Baseline and discharge from OT (3 to 8 weeks)
Diabetic Foot Ulcer
Diabetic Foot
1 sites across 1 states
California1

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Eligibility criteria

Inclusion

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

Self-reported deafness or blindness
history of lower extremity amputation besides toes
  • Patient satisfaction (change from baseline)Baseline and discharge from OT (3 to 8 weeks)

    Participants will fill out a general satisfaction survey, adapted from and comprising 18 items from a validated measure: Short-Form Patient Satisfaction Questionnaire (PSQ-18). The scale ranges from 1 (strongly agree) to 5 (strongly disagree).