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Smart Boot Use to Measure Offloading Adherence

StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated January 16, 2026 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary endpoints revised (2)v11 Show 7 more changesShow less
    • Primary completion date: Dec 1, 2025 to Mar 31, 2026
    • Study completion date: Dec 31, 2025 to Mar 31, 2026
    • Interventions: Boot (Device) to Offloading Boot (Device)
    • Eligibility criteria expanded, about 65 words
    • Secondary endpoints: 2 to 4
    • Site contacts updated at 4 of 4 sites
    • Collaborator revised
  2. Notable Phase: Not applicable to Phase 2
    • Enrollment target: 250 to 210
    • Primary completion date: Dec 2025 to Dec 1, 2025
    • Study completion date: Dec 2025 to Dec 31, 2025
    v10
  3. Notable Phase: Phase 2 to Not applicablev9
  4. Minor Site contacts updated at 1 of 4 sitesv8
  5. Minor Study sites: 2 to 4v7
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Site contacts updated at 1 of 2 sitesv6
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2021 to Oct 19, 2021
    • Study sites: 0 to 2
    v5
  3. Notable Phase: Not applicable to Phase 2
    • Secondary endpoints: 1 to 2
    v4
  4. Notable Primary completion date: Jan 2025 to Dec 2025
    • Start date: Sep 2020 to May 2021
    • Enrollment target: 210 to 250
    • Study completion date: Aug 2025 to Dec 2025
    v3
  5. Minor Eligibility criteria expanded, about 3 wordsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 use removable offloading with reinforced education emphasizing continuous wear, including during rest and sleep, and not to remove it at any time. The second group will use removable offloading consistent with standard of care and receive education on recommended wear during walking or standing, with permission to remove the device during rest and sleep. The third group will use a smart removable offloading device that provides real-time adherence feedback via a smartwatch and smartphone, with additional personalized education informed by remotely monitored adherence data. 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.
Trial Details
NCT Number NCT04460573
Lead Sponsor University of Southern California
Collaborators: University of California, Los Angeles
Conditions
(from sponsor)
Diabetic Foot Ulcer
Related terms Diabetic Foot
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov