Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Diabetic Foot Ulcer, sponsored by University of Southern California.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Wound healing is defined as complete epithelialization of the target ulcer, confirmed by standardized wound assessment. Healing status is recorded as a binary outcome (yes/no) for each participant. The proportion of participants achieving wound healing by 12 weeks is compared between randomized treatment arms. Unit of Measure: %
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 |
What NCT04460573 shows while recruiting
NCT04460573 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 252-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (17% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04460573's enrollment target sits among peer trials
210 17th of 67 higher than 51 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.
RECRUITING · Phase 2
-
A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers
RECRUITING · Phase 2
-
Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers
COMPLETED · Phase 2
-
Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers
COMPLETED · Phase 2
-
Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)
COMPLETED · Phase 2
-
Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02665923 · 210 participants
Gastric Emptying in Neonates and Infants After Formula Feeding
- NCT03322891 · 210 participants · NA
Improving Health Literacy in African-American Prostate Cancer Patients
- NCT03544489 · 210 participants · Phase 2
Effectiveness of Exercise After an ICD
- NCT04408430 · 210 participants · NA
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI