Smart Boot Use to Measure Offloading Adherence

Recruiting Phase 2 Interventional Study
Diabetic Foot Ulcer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
210 (estimated)
Sponsor
University of Southern California · Other
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About This Trial
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 kin…
Trial Locations
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Eligibility Criteria
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 \<…
Contacts

Fabiola Rodriguez, MD

3235162332

fabiola.rodriguez@med.usc.edu

CONTACT

Bijan Najafi, PHD

5244677127

bnajafi@mednet.ucla.edu

CONTACT