Language

English

Publication Date

7-19-2025

Journal

Sensors

DOI

10.3390/s25144490

PMID

40732618

PMCID

PMC12299288

PubMedCentral® Posted Date

7-29-2025

PubMedCentral® Full Text Version

Post-print

Abstract

Diabetic foot ulcers (DFUs) are a serious complication of diabetes, associated with high recurrence and amputation rates. Adherence to offloading devices is critical for wound healing but remains inadequately monitored in real-world settings. This study evaluates the SmartBoot edge-computing system-a wearable, real-time remote monitoring solution integrating an inertial measurement unit (Sensoria Core) and smartwatch-for its validity in quantifying cadence and step count as digital biomarkers of frailty, and for detecting adherence. Twelve healthy adults wore two types of removable offloading boots (Össur and Foot Defender) during walking tasks at varied speeds; system outputs were validated against a gold-standard wearable and compared with staff-recorded adherence logs. Additionally, user experience was assessed using the Technology Acceptance Model (TAM) in healthy participants (n = 12) and patients with DFU (n = 81). The SmartBoot demonstrated high accuracy in cadence and step count across conditions (bias < 5.5%), with an adherence detection accuracy of 96% (Össur) and 97% (Foot Defender). TAM results indicated strong user acceptance and perceived ease of use across both cohorts. These findings support the SmartBoot system's potential as a valid, scalable solution for real-time remote monitoring of adherence and mobility in DFU management. Further clinical validation in ongoing studies involving DFU patients is underway.

Keywords

Humans, Male, Female, Wearable Electronic Devices, Adult, Middle Aged, Diabetic Foot, Walking, Monitoring, Physiologic, Aged, Monitoring, Ambulatory, offloading, adherence, diabetic foot ulcer, wound care, telemedicine, digital health, remote patient monitoring, wearables, smart footwear, personalized care, edge computing

Published Open-Access

yes

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