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RECRUITING
NCT06487780
NA

Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers

Sponsor: University of Southern California

View on ClinicalTrials.gov

Summary

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.

Official title: Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06-11

Completion Date

2026-06-30

Last Updated

2025-06-22

Healthy Volunteers

No

Interventions

BEHAVIORAL

Lifestyle-focused Occupational Therapy Intervention

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.

OTHER

Education

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.

Locations (3)

Rancho Los Amigos National Rehabilitation Center

Downey, California, United States

Keck Hospital of USC

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States