Diabetic Foot Imaging Scanner(DFIS)

描述（由申请人提供）：DFIS Eden Medical, Inc.很高兴提交这一修订的第二阶段SBIR提案，以开发红外“糖尿病足成像扫描仪（DFIS）”，以展示捕获动态热图像和识别与重复应力相关的热点的能力。糖尿病足部伤口是常见的、复杂的和昂贵的。由于炎症和组织的酶解作用，可能发生溃疡的足部区域与局部皮肤温度升高有关。炎症的主要特征是：发红、肿胀和发热。DFIS成像的重点是提供量化炎症的所有三种迹象的能力，并在它们导致溃疡之前识别病理变化。拟议的第二阶段项目的主要目标是：1)展示捕获足部动态热图像的能力，识别糖尿病患者的热点和炎症模式；2)采用糖尿病足部创面的热指标——创面炎症指数（Wii）对创面愈合进行量化评估；3)将Wii的时间行为（在伤口愈合期间量化）与风险评估阶段双足对侧部位温差的4度家庭监测标准相关联，以降低溃疡风险。

DESCRIPTION (provided by applicant): DFIS Eden Medical, Inc. is pleased to submit this revised Phase 2 SBIR proposal to develop the infrared "Diabetic Foot Imaging Scanner (DFIS)" to demonstrate the ability to capture dynamic thermal imagery and identify hot spots associated with repetitive stress. Diabetic foot wounds are common, complex and costly. Foot areas that are likely to ulcerate are associated with increased local skin temperature due to inflammation and enzymatic autolysis of tissue. Inflammation is characterized by the cardinal signs of: degree of redness, swelling, and heat. The key focus of DFIS imaging is to provide the capability to quantify all three signs of inflammation and identify pathological changes before they result in ulceration. The key goals of the proposed Phase 2 project are to: 1) to demonstrate the ability to capture dynamic thermal imagery of the feet, identify hot spots and inflammatory patterns in patients with diabetes; 2) to assess the quantification of wound healing using wound inflammatory index (Wii), a thermal index for diabetic foot wounds; 3) to associate the temporal behavior of Wii (quantified during wound healing) with 4 degree F home monitoring criteria for temperature differences between contra lateral sites on both feet during risk assessment phase with the intent to reduce ulceration risk. PUBLIC HEALTH RELEVANCE: To develop a point-of-care infrared imaging system that scans around the foot of a diabetic patient to assess and associate patterns of inflammation to reduce risk of ulceration.