RecruitingNot ApplicableNCT06487780

Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers

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


Sponsor

University of Southern California

Enrollment

60 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 21 Years

Inclusion Criteria3

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

Exclusion Criteria4

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

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Interventions

BEHAVIORALLifestyle-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.

OTHEREducation

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

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NCT06487780


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