SBIR-STTR Award

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.

Thesaurus Terms:
diagnosis design /evaluation, disease /disorder proneness /risk, foot, hemoglobin, imaging /visualization /scanning, insulin dependent diabetes mellitus, peripheral blood vessel, skin ulcer, wound healing longitudinal human study bioimaging /biomedical imaging, clinical research, human subject, patient oriented research

Foot disease complications seriously impact lives of people with Type 1 diabetes. A quantitative method to evaluate efficacy of therapy, or better, to define tissue at risk & prevent initial ulcer formation would be highly beneficial. HYPERMED'S long-term objective is to reduce frequency of foot ulcers & amputation by developing Foot HyperSpectral Imaging (FHSI) as a camera-based system to 1) identify tissue at risk for ulceration, 2) evaluate an existing ulcer & predict capability of tissue to heal & 3) monitor efficacy of therapy. FHSI provides a 2-D image with spectral data inherent in each pixel which reflects the presence & concentration of various chemical species that represents a "gradient map" of components. Our Phase II goal is to validate FHSI as a quantitative anatomic metric for assessing therapeutic progress of foot ulcers seen in Type 1 diabetes & identify tissue at risk for future ulceration to assist in prevention. We will build on advances from proof of principle Phase I data & on our other work. Specific aims are to: 1)build upgraded FHSI systems for use at 4 well-respected diabetic clinics with strong Type 1 patient volume in statistically- powered studies, 2)study 50 Type 1 patients with manifest foot ulcers for 6+ months to assess healing or progression, 3)study 160 Type 1 patients at high risk for foot ulceration in a 24-month longitudinal study aimed at predicting ulceration, 4)develop algorithms that will deliver a Hyperspectral Microvascular Index that can be used as a biomarker for tissue viability & wound healing & give a spatial quantitation of risk & 5)validate merit in further developing FHSI using clinical outcome measures & comparing FHSI with existing methods (ABI, laser Doppler, TCPO2) to determine advantages & limitations of FHSI in clinical foot care. Our collaborative effort with the Hospital for Joint Disease, the Cleveland Clinic, Olive View UCLA Medical Center, and the Beth-Israel Deaconness medical centers will be highly advantageous in meeting our specific aims during this research program. FHSI delivers metabolic information about tissue in an easily interpretable picture that correlates with anatomy. This adds a new dimension to assessment of ulceration risk & tissue healing & allows physicians to target care to specific at risk areas earlier than previously possible. FHSI has clear potential to be a cost effective, easy to use, turn-key camera based tool. If successful, FHSI will address two Healthy People 2010 goals: "Reduce the frequency of foot ulcers in persons with diabetes" & "Reduce the rate of amputations in persons with diabetes". We believe FHSI can have positive impact on quality of life of people with diabetes, impacting morbidity & mortality & lowering overall healthcare costs.

Thesaurus Terms:
diagnosis design /evaluation, disease /disorder proneness /risk, foot, hemoglobin, imaging /visualization /scanning, insulin dependent diabetes mellitus, peripheral blood vessel, skin ulcer, wound healing computer program /software, computer system design /evaluation, longitudinal human study bioimaging /biomedical imaging, clinical research, human subject, patient oriented research