A system to enhance prevention of diabetic foot ulcers and their recurrence

Project Summary/Abstract Problem The prevalence of diabetes mellitus in the U.S. is high and increasing in both adults and children—over 1.5 million Americans are diagnosed with diabetes annually. Among the consequences of diabetes, diabetic foot ulcers (DFUs) are a common and major complication, resulting in lower quality-of-life, hospitalization, disability, amputation, and even death. DFUs are the leading cause of hospitalization and disability in patients with diabetes, and are the largest category of excess medical costs associated with diabetes. In light of the impending diabetes epidemic and the high prevalence and grave consequences of DFUs, the need for improved prevention of DFUs and their recurrence is clear. The major risk factors for DFUs include diabetic peripheral neuropathy, peripheral arterial disease (PAD), higher pressure on plantar surfaces, and an unsteady gait. DFUs can arise from acute trauma or from recurrent weight-bearing activity that is undetectable by the patient due to insensate feet. Research suggests that active management of foot health can prevent the occurrence and reoccurrence of a DFU; however, approaches must be multifaceted and require continual monitoring from both patients and caregivers. Solution The SoleSaver system is a sensor-enabled, unobtrusive, and non-binding foot-worn garment similar to a sock that can be used to continually monitor multiple facets of foot health in order to maximize DFU prevention and minimize DFU recurrence. SoleSaver measures both the pressure and temperature across the plantar surface, tracks gait indices, and provides an index for PAD status and changes thereto. SoleSaver also measures adherence to use of offloading or other prescribed footwear. SoleSaver collects data continuously and relays measurements wirelessly to a portable computing device (e.g., a smartphone). A specialized software application automatically generates interpretive reports for clinicians, sends reminders, and delivers timely alerts and warnings to the patient. Compiled data and results are also offloaded to a secure, cloud-based provider dashboard. The provider dashboard enables caregivers to securely and remotely review patient data and provide clinical feedback and advice (e.g., “we need to adjust your offloading footwear”) without the need for burdensome and costly office visits that only provide a snapshot picture of the patient’s foot health. The SoleSaver software automatically generates clear, concise reports that include summary data to simplify interpretation by clinicians. SoleSaver fulfills the need for an ergonomic, accurate, reliable, and low-cost DFU prevention system for use in healthcare and clinical research. The proposed Phase I SBIR effort will demonstrate proof-of-concept and feasibility for the SoleSaver method- ology via rigorous evaluation of a Phase I prototype on patients with diabetes and age- and sex-matched healthy participants.