Hyperspectral Imaging to Predict and Assess Foot Ulcers

描述（由申请人提供）： 解决足部疾病并发症的新疗法将显著影响1型糖尿病患者的生活。一种定量方法来评估治疗方案的疗效，或更好地确定风险问题并防止初始溃疡形成将是非常有益的。我们的长期目标是通过开发用于微血管评估的高光谱成像（HIMA）来降低糖尿病足溃疡（DFU）的频率并降低1型糖尿病患者的截肢率。在高光谱成像中，创建具有每个像素中固有的光谱数据的2维图像。可以将每个像素的光谱与各种化学物质的存在和浓度相关联，然后可以成为这些成分的“梯度图”。第一阶段的具体目标是：1）设计一种新的传感器，优化评估糖尿病足; 2）开发新的定量图像分析方法，以研究皮肤代谢，包括现有DFU附近的皮肤（溃疡大小，O2 Sat，THb，肉芽组织）; 3）对30名I型糖尿病患者和15名正常受试者进行临床可行性研究。HIMA测量将主要测量反映皮肤灌注和氧提取的生物标志物。在第1阶段，我们提出测试三个假设：1）DFU周围皮肤中氧饱和度（O2 Sat）和总血红蛋白（THb）的空间分布定义愈合潜力; 2）DFU附近O2 Sat和THb的空间变化反映微血管疾病进展和组织存活率; 3）O2 Sat和THb空间模式变化可以定义风险组织并提供DFU预测/早期检测。DFU和15名正常受试者。HIMA可以潜在地预测存在DFU风险的组织;预测现有DFU中能够愈合的组织;监测疗效/开发新的治疗方案。一旦证明了可行性，第二阶段的进一步工作将在大型临床试验中使用HIMA来预测溃疡和伤口愈合的组织风险。作为一种基于摄像头的、非侵入性的、快速的系统，HIMA非常适合在临床上使用，具有广泛的商业化潜力。

DESCRIPTION (provided by applicant): New therapies addressing complications of foot disease would significantly impact the lives of people with Type 1 diabetes. A quantitative method to evaluate the efficacy of a therapeutic regimen, or better, to define issue at risk and prevent initial ulcer formation would be highly beneficial. Our long-term objectives are to reduce the frequency of diabetic foot ulcers (DFU) & decrease the amputation rate in Type 1 diabetics by developing Hyperspectral Imaging for Microvascular Assessment (HIMA). In hyperspectral imaging a 2-dimensional image is created that has spectral data inherent in each pixel. It is possible to correlate the spectrum of each pixel with the presence & concentration of various chemical species that can then become a "gradient map" of these components. Specific aims of Phase I are to 1) design a novel sensor optimized to assess diabetic feet; 2) develop new quantitative image analysis methods to investigate skin metabolism including skin near an existing DFU(ulcer size,O2Sat,THb, granulation tissue); 3)perform clinical feasibility studies on 30 Type I diabetics with & without DFU &15 normal subjects. HIMA measurements will primarily measure biomarkers reflecting skin perfusion and oxygen extraction. In Phase 1 we propose to test three hypotheses: 1)spatial distributions of oxygen saturation (O2Sat) & total hemoglobin (THb) in skin around a DFU define healing potential; 2)spatial changes in O2Sat and THb near a DFU reflect microvascular disease progression and tissue survivability; 3)O2Sat & THb spatial pattern variations may define tissue at risk & provide DFU prediction/early detection. DFU and 15 normal subjects. HIMA can potentially predict tissue at risk for DFU; predict tissue in an existing DFU capable of healing; monitor efficacy/ develop new therapeutic regimens. Once feasibility is demonstrated, further work in Phase II will employ HIMA to predict tissue at risk for ulceration and wound healing in a large clinical trial. As a camera-based, non-invasive, rapid system well suited for use in the clinic HIMA has the potential for broad commercialization.