Smart Boot Use to Measure Offloading Adherence
The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of amputation. Part of the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. Sometimes people don't wear the boot like they are told. The investigators want to compare three different kinds of diabetic boots to see if they can help make it easier for people to wear their boots as instructed. The investigators will look at three groups of participants: the first group will wear a boot that can't be taken off. The second group will wear a boot that can be taken off, and they will get counseling about how important it is to follow instructions as to how often and when to wear the boot. The third group will wear a "smart" boot, which will interact with the person through a smart watch and smart phone, and give them direct feedback about how they are doing with following their boot wearing prescription. The investigators will also be looking at how much physical activity, like walking, the participants do. And they will compare how well participants sleep and rate their quality of life in the three different boots. The investigators think that giving participants information about how much they are wearing their boot using readily available technology will help them to follow the doctor's directions better, and help their wounds heal faster.
Conditions:
🦠 Diabetic Foot Ulcer
🗓️ Study Start (Actual) 19 October 2021
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 250
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Downey, California, United States
📍 Glendale, California, United States
📍 Los Angeles, California, United States
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Male or Female aged 18 or older
    • * Diabetic Foot Ulcer requiring offloading
    • * Able to provide written informed consent

    Exclusion Criteria:

    • * Wound present for more than one year
    • * HbA1c \> 12%
    • * Ankle Brachial Index (ABI) of index limb is \<0.9 and/or they are being considered for revascularization within the course of the study
    • * Ulcer involving bone or tendon
    • * Ulcer not caused by diabetes
    • * Unable or unwilling to attend prescribed clinic visits
    • * Fully confined to a wheelchair
Ages Eligible for Study: 18 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 1 July 2020
  • First Submitted that Met QC Criteria 1 July 2020
  • First Posted 7 July 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 July 2024
  • Last Update Posted 3 July 2024
  • Last Verified July 2024