Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers

Part of paid clinical trials in Downey, California.

Sponsor
University of Southern California
Study ID
NCT06487780
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lifestyle-focused Occupational Therapy Intervention — BEHAVIORAL
    The proposed intervention, led by trained occupational therapists, will focus on establishing sustainable self-care routines. It will consist of approximately 12 biweekly sessions, each lasting about an hour on average. Therapists will customize session timing and duration based on participant needs.
  • Education — OTHER
    Participants in the education group will receive standardized education materials on diabetic foot ulcers (DFUs), foot care, and offloading treatment to prevent foot ulcer recurrence.

Study Details

People with diabetes often experience foot ulcers, which can harm their ability to move, lower their quality of life, and increase the chances of losing a limb. These diabetic foot ulcers (DFUs) commonly come back (recur) even after they've healed, so it's crucial to stop them from returning to avoid toe, foot , or leg amputation. While wearing special shoes to reduce pressure on the feet is essential for healing and preventing DFUs, many people struggle to follow this treatment plan once their ulcers have healed. This study aims to see if a lifestyle-focused program can help participants create daily routines and habits that make it easier to consistently use special shoes and take care of their diabetes and feet to prevent ulcers from recurring.

Key Dates

Start date
Jun 11, 2025
Status verified
Jun 2025
Primary completion
Jun 1, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Lifestyle-focused Occupational Therapy (OT) Intervention
    Participants in the intervention group will engage in telemedicine sessions led by trained occupational therapists.
  • Active Comparator: Education
    Participants in the control group will receive standard education on foot self-care and offloading treatment aimed at preventing foot ulcer recurrence.

Primary Outcome Measure

Numbers of participants who have completed the study [ Time Frame: 6-month ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Rancho Los Amigos National Rehabilitation CenterDowneyCalifornia90242
Tze Woei Tan
Keck Hospital of USCLos AngelesCalifornia90033
Tze-Woei Tan
Stacey Schepens Niemiec, PhD (SUB_INVESTIGATOR)
Los Angeles General Medical CenterLos AngelesCalifornia90033
Tze-Woei Tan
Stacey Schepens Niemiec (SUB_INVESTIGATOR)

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By research site
Rancho Los Amigos National Rehabilitation Center· Downey, CAKeck Hospital of USC· Los Angeles, CALos Angeles General Medical Center· Los Angeles, CA

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