SBIR-STTR Award

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to provide a new class of soft, flexible, nonabrasive sensing elements which provide precise temperature readings to positively impact the health and mobility of diabetic patients. The principle impetus of this research is to focus primarily on advanced diabetic patients who suffer from nerve damage to their feet. These patients cannot feel their feet, leading to two important and related results. First, they are at high risk for an increased number of undetected ulcerating injuries from tissue damage produced by walking (friction) or standing (pressure). Second, since these injuries are undetected and unfelt, there is a decreased urgency by the patient to seek medical care. Delays in medical intervention further exacerbate injuries and complicate treatment, leading to an economic burden associated with foot ulceration estimated at $15 billion annually. More importantly, the 5-year mortality rate after first ulceration (40%) approaches mortality rates from heart failure (50%). The key need for a simple and cost-effective ulcer-prevention paradigm is a safe, easy-to-use foot monitoring system with temperature-sensing capability with a remote readout. The proposed project utilizes an innovative approach to develop a non-invasive sensing system that will provide the ability to constantly monitor skin temperature. Skin temperature has been shown to be a predictive indicator of foot-ulcer development and can additionally be used as a measure of wound healing. A simple system enabling early detection of imminent skin ulceration subsequently reduces further tissue damage, decreasing limb amputations and saving financial, medical and emotional resources. The proof of concept sensor is designed to reside daily in a patient?s shoe to record temperatures while the patient experiences damaging activity such as walking or standing, alerting the patient to impending tissue injury. The sensor can also reside daily in a patient?s medical-treatment cast, providing a constant readout of skin temperature indicating tissue healing, allowing for out-patient monitoring and decreasing repeated visits to medical facilities for checkups.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to provide a new class of soft, flexible, nonabrasive sensing elements which provides precise temperature readings to positively impact the health and mobility of diabetic patients. The principle impetus of this research is to focus primarily on advanced diabetic patients who suffer from nerve damage to their feet. These patients cannot feel their feet, leading to two important and related results. First, they are at high risk for an increased number of undetected ulcerating injuries from tissue damage produced by walking (friction) or standing (pressure). Second, since these injuries are undetected and unfelt, there is a decreased urgency by the patient to seek medical care. Delays in medical intervention further exacerbate injuries and complicate treatment, leading to an economic burden associated with foot ulceration estimated at $15 billion annually. More importantly, the 5-year mortality rate after first ulceration (40%) approaches mortality rates from heart failure (50%). The key need for a simple and cost-effective ulcer-prevention paradigm is a safe, easy-to-use foot monitoring system with temperature-sensing capability with a remote readout. The proposed project utilizes an innovative approach to develop a non-invasive sensing system that will provide the ability to constantly monitor skin temperature that would be integrated into a diabetic-friendly insole. Skin temperature has been shown to be a predictive indicator of foot-ulcer development and can additionally be used as a measure of wound healing. A simple system enabling early detection of imminent skin ulceration subsequently reduces further tissue damage, decreasing limb amputations and saving financial, medical and emotional resources. The proof of concept shoe insert is designed to reside daily in a patient's shoes to continuously record the patient's foot health. In addition, the software system, including a mobile app for users as well as a doctor dashboard, is developed as a communication channel between the patient, the healthcare provider and the caregiver. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.