Diabetic foot ulcers are extremely costly and debilitating. The cost of care doubles in patients with diabetic foot ulcers compared to patients without ulcers. Even if an ulcer heals, there is a 30%-40% risk there will be a recurrence within one year, so the problem is not likely to go away once it has started. The presence of ulcers and the potential necessity of an amputation both lead to dramatic decreases in both the quality of life and overall health of people with diabetes. The biomechanical and physiological etiology of diabetic ulceration is associated with damaging magnitudes of plantar pressures, shear forces and temperatures within inadequate or ill-fitting footwear. Prevention strategies are needed that target all of these modifiable factors. However, to- date, commercially available clinical systems used to measure the plantar surface only capture plantar pressures, and do not quantify shear forces or temperature of the environment. Currently, if interventions or advanced orthotics are designed to target skin-damaging shear forces and temperatures, these attributes cannot be measured to validate and test the effectiveness of the intervention. To fill this considerable gap in available technology in the care of diabetic patients, RTC Electronics, Inc. has developed a unique, patented Multi-Capacitor Sensor Array (MCSA) technology (Issued Patents #US7,343,813 B1 and US9250143 B2) that can sense both axial and shear forces, quantify temperature, and can be fabricated on very thin flexible substrates to fit within the footwear. The overall goal of the technology development proposed by RTC Electronics, Inc. is to develop a superior planter surface and foot function analysis system for clinical use to aid in the evaluation of orthotics and interventions that prevent diabetic foot ulcers. The specific goal of this application is to complete the initial development of our in-shoe axial and shear force, pressure, and temperature sensor, complete a thorough validation of the sensor, and to gather feedback from the clinical end-users of the system on current and future design factors.
Adults with diabetes and neuropathy in their feet often have foot ulcers because of walking barefoot and ill- fitted footwear. Custom foot-wear (orthotics) can be made to prevent ulcers using force and pressure measure sensors that fit inside a shoe. There are commercially available sensors currently, but they do not measure all the important variables including temperature and shear force. This project will focus on developing an advanced in-shoe sensor that measures axial force, shear force and temperature to improve our ability to prevent diabetic foot ulcers.
