Recruiting

Lifestyle-Focused Intervention

Sponsor:

University of Southern California

Code:

NCT06278935

Conditions

Diabetic Foot Ulcer

Diabetic Foot

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Lifestyle-based intervention by an occupational therapist

Study Details

Brief summary:

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.

Conditions

Diabetic Foot Ulcer

Diabetic Foot

Study ID

NCT06278935

Start date

Feb 10, 2025

Status verified date

May, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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 measure

  • Patient satisfaction (change from baseline) [ Time Frame: Baseline and discharge from OT (3 to 8 weeks) ]

Central Contacts and Locations

Central contacts

Tze Woei Tan

3234426835tze-woei.tan@med.usc.edu

Jason Garcia

3234426835jason.Garcia@med.usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Tze-Woei Tan

323-442-6835tze-woei.tan@med.usc.edu

Stacey Schepens Niemiec, PhD

323-442-2069schepens@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

May 18, 2025

Last verified

May, 2025

Keywords

  • Offloading diabetic foot ulcer
  • Lifestyle-focused intervention
  • Occupational therapy
  • Occupational therapist
  • Self management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2025-05-18.