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Smart Boot Use to Measure Offloading Adherence | Clinical Trials | Clareo Health

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RECRUITINGPhase 2NCT04460573

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 ...

Lead sponsor: University of Southern California•4 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Fabiola Rodriguez, MD

CONTACT

3235162332 fabiola.rodriguez@med.usc.edu

Bijan Najafi, PHD

CONTACT

5244677127 bnajafi@mednet.ucla.edu

Sponsors

Lead Sponsor

University of Southern California

Collaborators

University of California, Los Angeles

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Male or female
•≥18 years old
•Non-infected, non-ischemic DFU requiring offloading
•Ambulatory at home with or without assistance
•Willing and able to provide written informed consent

Exclusion Criteria

•Wound present for \> 1 year
•HbA1c \> 12%
•ABI of index limb \< 0.6 or non-detectable Doppler, and/or patient being considered for revascularization during the course of the study
•Acute Charcot neuropathy or a major foot deformity that doesn't allow them to wear the smart boot
•Amputation proximal to the rearfoot on the affected extremity
•Any clinically significant medical or psychiatric condition
•Laboratory abnormality that would interfere with the ability to participate in the study
•Concurrently participating in exercise training
•Changes in psychotropic or sleep medication in the last 6 weeks
•Ulcer involves bone
•Ulcer not of diabetic origin
•Unable or unwilling to attend prescribed clinic visits or comply with protocol

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 16, 2026Terms

Trial snapshot

StatusRECRUITING

PhasePHASE2

Enrollment210

Start dateOct 2021

Last updatedJan 16, 2026

Condition

Diabetic Foot Ulcer

Locations shown

Rancho Los Amigos National Rehabilitation Center

Downey, California

Verdugo Hills Hospital of USC

Glendale, California

Clemente Clinical Research

Los Angeles, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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