Hyperspectral Imaging to Predict and Assess Foot Ulcers

描述（由申请人提供）：

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.