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Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers
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 Start (Actual) 1 September 2024
🗓️ Primary Completion (Estimated) 30 June 2026
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Downey, California, United States
📍 Los Angeles, California, United States
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 21 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 27 June 2024
  • First Submitted that Met QC Criteria 27 June 2024
  • First Posted 5 July 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 July 2024
  • Last Update Posted 22 July 2024
  • Last Verified July 2024