Thermal Imaging Modality for Detection of Large and Small Fiber Diabetic Peripheral Neuropathy.

摘要 糖尿病周围神经病变(DPN)是糖尿病常见的世界性并发症 (DM)。根据美国疾病控制与预防中心2017年的统计数据，有3020万美国人报告 糖尿病患者每年新增糖尿病患者140万例。至少50%的患者 糖尿病患者在一生中的某个时候会患上DPN，高达20%的人在 糖尿病诊断。DPN可导致15%的糖尿病患者截肢或截肢，这一比例为8.2万 美国每年都会发生截肢手术。因此，一种准确的检测手段 早期DPN的存在是改善预后的关键，当干预 最有效的。 VisionQuest Biomedical组建了一个合作者团队，代表一个跨学科的 一群在自动热图像分析方面拥有丰富经验的科学家，糖尿病 共病诊断和治疗，以及DPN和足科的专门研究。这支队伍 将继续开发和测试i-RxTherm™，这是我们的专利设备，其原理是 皮肤血流量受多种神经因子调节，这些神经因子受糖尿病的影响。 反过来，改变DPN患者的体温调节过程。这种方法能够检测到 小纤维或大纤维神经病的影响。I-RxTherm集成了热成像摄像头和 全自动热像分析软件，将提高诊断的准确性 DPN，导致目前被遗漏的DPN患者数量较少 可用的临床工具。I-RxTherm的核心创新是它能够检测任何类型的DPN， 即小光纤DPN和大光纤DPN，这是目前没有其他单个设备具有的能力 这将使其成为医生进行DPN筛查的标准护理。 在第二阶段，我们开发了图像分析软件，利用足底的热视频来检测DPN 表现优异的足部，敏感度85%，特异度75%。 在第二阶段成功的推动下，第二阶段B的主要目标是将该设计投入商业 通过产品化过程，使其准备好在筛选中广泛使用。 在该项目结束时，i-RxTherm将处于商业准备阶段，来自 第三方投资者被最大化。我们将通过以下具体措施实现这些目标 目标：1)设计和制造适合FDA测试的便携式设备，并验证其预期目标 使用。IRxTherm将在我们的合作者的设施--加州大学进行无干预测试 新墨西哥州临床与翻译科学中心；2)进行临床研究，以验证 商用iRxTherm。这项临床研究将招募N=336名被诊断为 糖尿病。该样本大小是基于统计功率分析确定的，以拒绝零 我们主要终点的假设(灵敏度/特异度为85%/75%)。 到拨款的第二年结束时，i-RxTherm将在第三年开始进行临床试验 这符合FDA的所有要求。一旦通过，我们的临床合作者将成为最早的 I-RxTherm的采用者，它将成为DPN筛查的标准。

Summary Diabetic peripheral neuropathy (DPN) is a common, worldwide complication of diabetes mellitus (DM). According to the CDC statistics for year 2017, 30.2 million Americans were reported to have diabetes with 1.4 million new diabetic cases diagnosed every year. At least 50% of patients with diabetes will develop DPN sometime in their lives, and up to 20% have DPN at the time of diabetes diagnosis. DPN can result in foot or limb amputations in 15% of diabetics, with 82,000 lower extremity amputations occurring in the US annually. Therefore, an accurate means to detect the presence of early-stage DPN is critically needed to improve outcomes when intervention is most effective. VisionQuest Biomedical has assembled a team of collaborators representing an inter-disciplinary group of scientists with considerable experience in automated thermal image analysis, diabetes comorbidity diagnosis and treatment, and specialized research in DPN and podiatry. This team will continue to develop and test i-RxTherm ™, our patented device based on the principle that skin blood flow is regulated by several neuronal factors that are affected by diabetes, which in turn, alter the thermoregulation process in DPN patients. This approach enables the detection of the effect of small or large fiber neuropathy. i-RxTherm integrates a thermal imaging camera and a fully automated thermal image analysis software, that will increase the diagnostic accuracy for DPN, leading to a smaller number of DPN patients that are otherwise missed by the currently available clinical tools. The core innovation of i-RxTherm is its ability to detect any type of DPN, namely small and large fiber DPN, a capability that no other single device currently has and one that will allow it to become the standard of care for DPN screening among physicians. In Phase II, we developed image analysis software to detect DPN using thermal videos of plantar foot that demonstrated excellent performance with sensitivity of 85% and specificity of 75%. Driven by the Phase II success, the main objective of Phase IIB is to put the devise on a commercial path through a productization process that will make it ready for widespread use in screening. At the end of this project, i-RxTherm will be at a commercial readiness stage where interest from third party investors is maximized. We will accomplish these goals through the following specific aims: 1) Design and build a portable device suitable for FDA testing and validate its intended use. iRxTherm will be tested non-interventionally at our collaborator’s facility, the University of New Mexico’s Clinical & Translational Science Center; 2) Conduct a clinical study to validate the commercial iRxTherm. The clinical study will enroll a cohort of N =336 subjects diagnosed with diabetes. This sample size is determined based on a statistical power analysis to reject the null hypothesis of our primary end point (sensitivity/specificity of <85%/75%). By the end of Year 2 of the grant, the i-RxTherm will enter into a clinical trial at the start of Year 3 that meets all FDA requirements. Once cleared, our clinical collaborators will become the early adopters of i-RxTherm where it will become the standard for DPN screening.