Diabetic Foot Imaging Scanner(DFIS)

描述（由申请人提供）：DFIS Eden Medical，Inc.很高兴提交这份修订后的第二阶段SBIR提案，以开发红外“糖尿病足成像扫描仪（DFIS）”，以展示捕获动态热成像和识别与重复性压力相关的热点的能力。糖尿病足伤口是常见的，复杂的和昂贵的。可能溃疡的足部区域与由于炎症和组织的酶自溶引起的局部皮肤温度升高有关。炎症的特征在于以下主要体征：发红、肿胀和发热的程度。DFIS成像的重点是提供量化所有三种炎症体征的能力，并在导致溃疡之前识别病理变化。拟议的第2阶段项目的主要目标是：1）证明捕获足部动态热成像的能力，识别糖尿病患者的热点和炎症模式; 2）使用伤口炎症指数（Wii）（糖尿病足部伤口的热指数）评估伤口愈合的量化; 3）在风险评估阶段，将Wii的时间行为（在伤口愈合期间量化）与双脚对侧部位之间温度差的4华氏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.