Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement + Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients @NIDDK @NIH #ActAgainstAmputation @USC @KeckMedUSC @bcmsurgery @sensoriainc

This just published in JDST highlights the first ever smart boot system designed to explore the boundaries of boosting adherence to care in people with diabetic foot ulcers.

Catherine Park 1 2 3Ramkinker Mishra 1Davide Vigano 4Maurizio Macagno 4Stefano Rossotti 4Karen D’Huyvetter 5Jason Garcia 5David G Armstrong 5 6Bijan Najafi 1

Background: A critical factor in healing diabetic foot ulcers is patient adherence to offloading devices. We tested a smart offloading boot (SmartBoot) combined with a smartwatch app and cloud dashboard to remotely monitor patient adherence and activity. In addition, the impact of SmartBoot on balance, gait, and user experience was investigated.

Methods: Fourteen volunteers (31.6±8.7 years; 64% female) performed natural activities (eg, sitting, standing, walking) with and without the SmartBoot for approximately 30 minutes. All participants completed balance tests, 10-meter walking tests at slow, normal, and fast pace while wearing the SmartBoot, and a user experience questionnaire. The accuracy of real-time adherence reporting was assessed by comparing the SmartBoot and staff observation. Center of mass (COM) sway and step counts were measured using a validated wearable system.

Results: Average sensitivity, specificity, and accuracy for adherence and non-adherence were 90.6%, 88.0%, and 89.3%, respectively. The COM sway area was significantly smaller with the SmartBoot than without the SmartBoot regardless of test condition. Step count error was 4.4% for slow waking, 36.2% for normal walking, 16.0% for fast walking. Most participants agreed that the SmartBoot is easy to use, relatively comfortable, nonintrusive, and innovative.

Conclusions: To our knowledge, this is the first smart offloading system that enables remote patient monitoring and real-time adherence and activity reporting. The SmartBoot enhanced balance performance, likely due to somatosensory feedback. Questionnaire results highlight SmartBoot’s technical and clinical potential. Future studies warrant clinical validation of real-time non-adherence alerting to improve wound healing outcomes in people with diabetic foot ulcers.

Keywords: adherence; diabetic foot ulcer; mobile health; remote monitoring; smart offloading boot.

David G. Armstrong

Dedicated to amputation prevention, wound healing, diabetic foot, biotechnology and the intersection between medical devices and consumer electronics.


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