Diabetic Foot Imaging Scanner(DFIS)

描述（由申请人提供）：Korosensor.com, Inc. （KI）提出了这项1期SBIR提案，开发一种红外“糖尿病足部成像扫描仪（DFIS）”，以减少高风险糖尿病患者足部溃疡的发生率。糖尿病足部伤口是常见的、复杂的和昂贵的。它们通常是由脚部的重复性压力引起的，引起炎症和皮肤破裂。重点是提供潜在破坏性炎症的早期检测和纠正治疗（即允许患者改变个人活动），以防止溃疡。拟议的I期项目的主要目标是验证DFIS系统与皮肤破裂临床症状相关的假设，证明能够降低高风险糖尿病患者糖尿病足溃疡的发生率。第二个目标是衡量干预措施在与健康有关的生活质量方面的效果。这些目标将通过具体的任务来完成，包括：足部成像扫描仪的硬件设计，图像采集协议和数据处理算法的开发以收集红外数据，提供用户界面支持，系统控制和校准，测试平台的组装以演示红外成像技术以减少溃疡发生率，以及在亚利桑那大学医学院进行人体受试者测试。糖尿病足成像扫描仪（DFIS）发展的关键焦点是提供早期识别炎症的主要症状（红肿和过热）导致溃疡。红外图像与基于治疗的糖尿病足数据的相关性，以确定患者的风险和行动过程。DFIS将展示识别重复性压力相关热点的能力，从而提供溃疡形成的早期预警。在人体测试期间，将对动态行为的病理变化（即易感区域的冷却浸泡）进行全面分析，以评估热感受器的反应。

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.