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.

Background: The lifetime risk of developing a diabetic foot ulcer (DFU) is at least 25%. A DFU carries a 50% risk for infection and at least 20% of those receive some form of amputation. The most significant parameter that prevents or delays ulcer healing is high plantar pressure. To improve the patient's healing process, the DFU's plantar pressure should remain cumulatively low. Therefore, a tool that continuously measures the DFU loading, and provides real-time feedback can improve the healing outcome. Methods:We report the development of a system capable of continuously measuring the pressure, which could have applications to monitor DFU. The system contains a textile pressure sensor attached to a stretchable band, hardware that collects data and transmits them via Bluetooth to a phone, an app that gathers the data and stores them in the cloud, and a web dashboard that displays the data to the clinician. The sensor was characterized in vitro using the system, and the webdashboard was developed and tested on simulated patient data. Results:We demonstrate the feasibility of developing the system and characterize the pressure response of the device. As a result, we demonstrate a viable method for monitoring DFU off-loading in real time. Conclusions:The presented study demonstrates the feasibility to develop a simple, modular wearable system that opens up new possibilities for diabetic foot ulcer care by providing a way of monitoring the pressure under the ulcer in real time.

Diabetic foot ulcers (DFUs) are serious complication of diabetes. Offloading devices treat DFUs by distributing force and reducing pressure across the wound. Adhering to appropriate use of offloading devices is a key strategy to promote DFU healing. However, some people who are highly adherent to offloading device use still do not heal. Factors such as wound and diabetes characteristics, motor function, and patient reported outcomes may help distinguish healed and non-healed patients. In our study, we analyzed data from 23 participants. Factors were graded on a scale from 0 to 10 based on thresholds found in the literature (Figure 1). We then calculated the effect size of each factor using Cohen's d between the healed and non-healed groups (Figure 2). Our results showed that cognition had the largest effect size, with a value of d = 1.63. Disclosure G.Cay: None. G.Finco: None. J.A.Garcia: None. E.Salazar: None. D.Vigano: Board Member; Sensoria Health Inc. M.Macagno: Board Member; Sensoria Health Inc. D.G.Armstrong: Research Support; Medaxis LLC. B.Najafi: Consultant; BioSensics LLC, Mölnlycke Health US, LLC, Research Support; AVAZZIA, EO2 Concept, LifeNet, Neurometrix, Medline, SmarTek21. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R01DK124789)