Project Description:

Diabetic foot ulcers (DFUs) represent a significant and dire complication of diabetes mellitus, often leading to amputation and even death. DFUs are caused by various risk factors, primarily polyneuropathy, vascular insufficiency, and secondary infections. Present preventive measures are rudimentary and involve unsophisticated techniques, like daily foot checks by patients and routine in-hospital screenings. However, given the multifaceted nature of DFU risks, there is a pressing need for a comprehensive solution. Our team has created the SoleAlert, a wearable device that monitors plantar pressure, moisture, and temperature to provide real-time feedback and data for early medical intervention to prevent DFU formation. The SoleAlert has 3 main components. Firstly, a flexible PCB embedded within an insole hosts an array of 12 sensor pressure sensors, including 8 FSR 402 UX pressure sensors capable of reading pressures up to 400kPA, along with thermistor temperature sensors and an AHT20 humidity sensor. Secondly, a sensor processing circuit with an attached battery is strapped to the top of the shoe sends processed data via WiFi. Lastly, a wristband equipped with lights and vibration receives sensor data wirelessly and presents warnings if the sensors readings indicate foot ulcer formation conditions. Using SoleAlert, diabetic patients can be notified of a potential ulcer in their feet, which they would not have found due to long-standing neuropathy. Not only can patients avoid thousands of dollars’ worth of hospital stays, toe or foot amputation operations, and antibiotics, but countless doctor appointments and hospital resources can be freed up. Furthermore, we calculate our Total Addressable Market (TAM) to be $17.4 billion and Serviceable Addressable Market (SAM) to be 75% of our TAM or $13 billion, given that 75% of DFUs can be avoided by early detection and proper care.