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NCT04460573 · ClinicalTrials.gov registry record · Phase 2
Smart Boot Use to Measure Offloading Adherence
A Phase 2 study of Diabetic Foot Ulcer, sponsored by University of Southern California.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 210
- Enrollment target
- 4
- Study locations
NCT04460573 is a Phase 2 study of Diabetic Foot Ulcer that is actively recruiting participants, run by University of Southern California. The registered enrollment target is 210 participants, below the 252-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (17% lower). The trial reports 4 study locations across 1 state.
The verdict
NCT04460573, a Phase 2 study of Diabetic Foot Ulcer, is actively recruiting participants, sponsored by University of Southern California.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 210 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Offloading Boot
Study Locations (4)
California
- Rancho Los Amigos National Rehabilitation Center - Downey
- Verdugo Hills Hospital of USC - Glendale
- Clemente Clinical Research - Los Angeles
- Keck Medical Center of USC - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04460573
The ClinicalTrials.gov registry entry for NCT04460573 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 252-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (17% lower). The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 1 intervention - of which Offloading Boot is the first listed.
NCT04460573 reports 4 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04460573 about?
NCT04460573 is a clinical study titled "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 ...
What is the current status of trial NCT04460573?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2021-10-19. Estimated completion is 2026-03-31.
What conditions does trial NCT04460573 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer.
What interventions are being tested in trial NCT04460573?
The interventions under investigation include: Offloading Boot (DEVICE).
Who is sponsoring clinical trial NCT04460573?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04460573 being conducted?
This trial has 4 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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