Recruiting

Lifestyle Intervention

Sponsor:

University of Southern California

Code:

NCT06487780

Conditions

Diabetic Foot

Diabetic Foot Ulcer

Foot Ulcer, Diabetic

Foot Wound

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Lifestyle-focused Occupational Therapy Intervention

Education

Study Details

Brief 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.

Conditions

Diabetic Foot

Diabetic Foot Ulcer

Foot Ulcer, Diabetic

Foot Wound

Study ID

NCT06487780

Start date

Jun 11, 2025

Status verified date

Jun, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >= 21 years
  • Healed diabetic foot ulcer within the past twelve months
  • Able to walk independently (use of a cane is acceptable)

Exclusion Criteria:

  • Current active diabetic foot ulcer
  • History of amputation beside toe or part of the foot
  • Non-ambulatory at baseline
  • Self-reported deafness/blindness.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Tze-Woei Tan, MD

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

Elaine Wong

3234426835wongelai@usc.edu

Locations

Keck Hospital of USC

Recruiting

Los Angeles, California, United States, 90033

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

More Information

Sponsor

University of Southern California

Last update posted

Jun 22, 2025

Last verified

Jun, 2025

Keywords

  • Diabetic foot ulcer, lifestyle intervention

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 2025-06-22.