Lifestyle Intervention for Preventing Recurrent Diabetic Foot Ulcers

This study is evaluating a lifestyle-focused program to help people who have had diabetic foot ulcers (DFUs) prevent them from coming back. DFUs are common in people with diabetes and can lead to serious problems, including amputation. Even after healing, DFUs often return. This study will compare a "Lifestyle-focused Occupational Therapy Intervention" with standard education materials. The occupational therapy intervention will involve about 12 sessions over several months, focusing on building self-care routines to help you consistently use special shoes and manage your diabetes. You may be able to join if you are at least 21 years old, have had a DFU heal within the last year, and can walk independently. The study aims to see how many participants complete the study after 6 months. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 60 participants. It compares a lifestyle-focused occupational therapy intervention with standard education.
What's involved
If you participate, you would receive either about 12 biweekly sessions of lifestyle-focused occupational therapy, each lasting about an hour, or standardized education materials.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 6 months, indicating participants will be followed for at least that long.

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NCT06487780

Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers

Recruiting
NAAges 21+InterventionalPrevention
University of Southern California
~60 participants
Updated 2025-06-22 on ClinicalTrials.gov
What's tested:Lifestyle-focused Occupational Therapy InterventionEducation

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Numbers of participants who have completed the study
Measured over 6-month
Diabetic Foot
Diabetic Foot Ulcer
Foot Ulcer, Diabetic
Foot Wound
3 sites across 1 states
California3
  • Tze Woei Tan · PRINCIPAL_INVESTIGATOR · University of Southern California

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Eligibility criteria

Inclusion

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

Exclusion

Current active diabetic foot ulcer
History of amputation beside toe or part of the foot
Non-ambulatory at baseline
Self-reported deafness/blindness.
  • Numbers of participants who have completed the study6-month

    Investigators will measure participant attendance, completion of planned/scheduled sessions, retention of participants in the intervention and education (control) groups.