NIH-Funded SmartBoot Study Demonstrates Real-Time Remote Monitoring Breakthrough for Diabetic Foot Ulcer Healing @NIDDKgov @NIH #Wearables #ActAgainstAmputation @researchatusc @keckschool_usc @USC @UCLA

LOS ANGELES, CA, July 21, 2025 — A newly published study in Sensors introduces the first validated real-time remote monitoring system for patient adherence and mobility in diabetic foot ulcer (DFU) management. The system, called SmartBoot, leverages wearable edge computing and a cloud-connected platform to track step count, cadence, and boot adherence with unprecedented accuracy—marking a significant milestone in diabetic limb preservation.

The collaborative study was led by researchers from the University of Southern California, Baylor College of Medicine, and the University of California, Los Angeles, and was funded by the National Institutes of Health (NIH) and the PhRMA Foundation. It is part of the ongoing SmartBoot clinical trial (ClinicalTrials.gov Identifier: NCT04460573).

The SmartBoot system combines an inertial measurement unit embedded in standard offloading boots with a smartwatch interface that provides real-time feedback to patients and clinicians. In this validation study, the system demonstrated adherence detection accuracy of 96%–97% and cadence tracking within 5.5% bias of a gold-standard gait analyzer.

“This study may be the first of its kind to validate a fully integrated, real-time adherence and mobility monitoring system for DFUs,” said Dr. Bijan Najafi, co-senior author and Director of the Center for Advanced Surgical & Interventional Technology (CASIT) at UCLA. “By integrating low-cost wearable sensors with intelligent edge computing, we’re enabling personalized care and earlier intervention—potentially preventing amputations.”

In addition to technical validation, the study assessed user experience through the Technology Acceptance Model (TAM). Over 80 participants with DFUs rated the SmartBoot system highly across domains of usability and willingness to continue use.

“We’ve long known that adherence to offloading is key to healing and preventing recurrence,” said Dr. David G. Armstrong, co-senior author, Distinguished Professor of Surgery and Neurological Surgery at USC. “With SmartBoot, we can finally monitor and support patients beyond the clinic—in real time, in the real world.”

The study, titled “SmartBoot: Real-Time Monitoring of Patient Activity via Remote Edge Computing Technologies,” is now available open access in Sensors:

 Read the full paper and author list

Citation: Cay G, Lee M, Armstrong DG, Najafi B, “SmartBoot: Real-Time Monitoring of Patient Activity via Remote Edge Computing Technologies,” Sensors, 2025;25(14):4490. https://doi.org/10.3390/s25144490 

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