Hyperspectral Assessment & Prediction of Diabetic Foot U

描述(申请人提供)：足部疾病并发症严重影响1型糖尿病患者的生活。一种量化的方法来评估治疗的效果，或者更好的方法，来确定危险组织并防止最初的溃疡形成，将是非常有益的。Hypermed的长期目标是通过开发足部高光谱成像(FHSI)作为基于相机的系统来减少足部溃疡和截肢的频率，以1)识别有溃疡风险的组织，2)评估现有的溃疡并预测组织的愈合能力，3)监测治疗的效果。 FHSI提供了具有每个像素固有的光谱数据的2-D图像，这些数据反映了各种化学物种的存在和浓度，代表了成分的“梯度图”。我们的第二阶段目标是验证FHSI作为评估1型糖尿病足溃疡治疗进展的定量解剖学指标&识别未来溃疡的风险组织，以帮助预防。我们将在第一阶段原则证明数据的基础上&在我们的其他工作上取得进展。具体目标是：1)建立升级的FHSI系统，用于4个备受尊敬的糖尿病诊所，在统计支持的研究中具有强大的1型患者数量；2)对50名患有明显足部溃疡的1型患者进行6个月以上的研究，以评估愈合或进展；3)在一项旨在预测溃疡的24个月的纵向研究中，研究160名具有足部溃疡高危风险的1型患者；4)开发算法，提供可用作组织存活和伤口愈合的生物标记物的高光谱微血管指数，并给出风险的空间量化；5)验证使用临床结果测量进一步发展FHSI的优点，并将FHSI与现有方法(ABI，激光多普勒，以确定FHSI在临床足部护理中的优势和局限性。我们与关节疾病医院、克利夫兰诊所、加州大学洛杉矶分校橄榄园医疗中心和贝丝-以色列执事医疗中心的合作将非常有利于实现我们在本研究计划期间的具体目标。 FHSI以一张与解剖学相关的、易于解释的图片提供有关组织的代谢信息。这为溃烂风险的评估增加了一个新的维度&组织愈合，使医生能够比以前更早地针对特定的高危区域进行治疗。FHSI显然有潜力成为一种具有成本效益、易于使用、基于交钥匙相机的工具。如果成功，FHSI将实现2010年健康人的两个目标：“减少糖尿病患者足部溃疡的频率”和“降低糖尿病患者的截肢率”。我们相信FHSI可以对糖尿病患者的生活质量产生积极影响，影响发病率和死亡率，并降低整体医疗成本。

DESCRIPTION (provided by applicant): 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.