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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• Age \>= 21 years

• Healed diabetic foot ulcer within the past twelve months

• Able to walk independently (use of a cane is acceptable)

Locations
United States
California
Rancho Los Amigos National Rehabilitation Center
NOT_YET_RECRUITING
Downey
Keck Hospital of USC
RECRUITING
Los Angeles
Los Angeles General Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Tze-Woei Tan, MD
tze-woei.tan@med.usc.edu
3234426835
Backup
Elaine Wong
wongelai@usc.edu
3234426835
Time Frame
Start Date: 2025-06-11
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Southern California

This content was sourced from clinicaltrials.gov