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.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Small Business Technology Transfer (STTR) Grants - Phase I (R41)
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Special Emphasis Panel (ZDK1-GRB-2 (O1))
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Jones, Teresa L Z
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Hypermed, Inc.
United States
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Khaodhiar, Lalita; Dinh, Thanh; Schomacker, Kevin T et al. (2007) The use of medical hyperspectral technology to evaluate microcirculatory changes in diabetic foot ulcers and to predict clinical outcomes. Diabetes Care 30:903-10
Greenman, Robert L; Panasyuk, Svetlana; Wang, Xiaoen et al. (2005) Early changes in the skin microcirculation and muscle metabolism of the diabetic foot. Lancet 366:1711-7