Diabetic Foot Imaging Scanner(DFIS)

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DESCRIPTION (provided by applicant): Korosensor.com, Inc. (KI) proposes this Phase 1 SBIR proposal to develop an infrared "Diabetic Foot Imaging Scanner (DFIS)" to reduce the incidence of foot ulcers for high-risk diabetic patients. Diabetic foot wounds are common, complex and costly. They are frequently caused by repetitive stress to the foot, causing inflammation and skin breakdown. The key focus is to provide early detection of potentially damaging inflammation and corrective treatment (I.e. allow the patient to modify personal activity) to prevent ulceration. The key goal of the proposed Phase I project is to test the hypothesis that the DFIS system correlated with the clinical signs of skin breakdown demonstrates the ability to reduce the incidence of diabetic foot ulcers in high-risk diabetic patients. A secondary objective is to measure the effect of the intervention in terms of health-related quality of life. These objectives will be accomplished through specific tasks including: hardware design of foot imaging scanner, development of image acquisition protocol and data processing algorithms to collect infrared data, provide user interface support, system control and calibration, assembly of a testbed to demonstrate infrared imaging technology for reduction of ulceration incidence, and human subject testing at the College of Medicine at the University of Arizona. PUBLIC HEALTH RELEVANCE: DFIS The key focus for the development of the Diabetic Foot Imaging Scanner (DFIS) is provide early identification of the cardinal signs of inflammation (redness, swelling, and excessive heat) leading to ulceration. The correlation of infrared imagery with treatment-based diabetic foot data to determine patient risk and course of action. The DFIS will demonstrate the ability to identify hot spots associated with repetitive stress to provide early warning of ulceration formation. A comprehensive analysis of pathological changes of dynamic behavior (i.e. cooling immersion of an area of susceptibility) to assess response of thermoreceptors will be performed during human subject testing.