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

总结 糖尿病周围神经病变（DPN）是一种常见的，世界范围内的糖尿病并发症 （DM）。根据CDC 2017年的统计数据，有3020万美国人被报告 每年有140万新的糖尿病病例被诊断出来。至少50%的患者 糖尿病患者在一生中的某个时候会发生DPN，高达20%的人在糖尿病发作时患有DPN。 糖尿病诊断DPN可导致15%的糖尿病患者的足部或肢体截肢， 每年在美国发生的下肢截肢。因此，一种准确的检测手段 早期糖尿病周围神经病变的存在是至关重要的， 最有效。 VisionQuest Biomedical组建了一个代表跨学科的合作者团队， 一组在自动热图像分析、糖尿病、 合并症的诊断和治疗，以及DPN和足病学的专门研究。这支球队 我们将继续开发和测试i-RxTherm ™，这是我们的专利设备，其原理是 皮肤血流量受糖尿病影响的几种神经因子调节， 反过来，改变DPN患者的体温调节过程。这种方法能够检测 小或大纤维神经病变的影响。i-RxTherm集成了热成像摄像头， 一个全自动的热图像分析软件，这将提高诊断的准确性， DPN，导致DPN患者的数量减少，否则目前的DPN患者会被遗漏。 可用的临床工具。i-RxTherm的核心创新在于它能够检测任何类型的DPN， 即小型和大型光纤DPN，这是目前没有其他单个设备具有的能力， 这将使其成为医生中DPN筛查的标准护理。 在第二阶段，我们开发了图像分析软件，利用足底热视频检测DPN 足部表现出良好的性能，敏感性为85%，特异性为75%。 在第二阶段成功的推动下，第二阶段的主要目标是将该设计投入商业使用。 通过一个产品化过程的路径，将使它准备在筛选中广泛使用。 在该项目结束时，i-RxTherm将处于商业准备阶段， 第三方投资者最大化。我们将通过以下具体措施实现这些目标： 目的：1）设计和构建适合FDA测试的便携式设备，并验证其预期用途 使用. iRxTherm将在我们的合作者的设施，大学进行非干预性测试。 新墨西哥州的临床和转化科学中心; 2）进行临床研究，以验证 商业iRxTherm.临床研究将入组N =336例诊断为 糖尿病该样本量是根据统计功效分析确定的，以拒绝零值 假设我们的主要终点（敏感性/特异性<85%/75%）。 在第二年结束时，i-RxTherm将在第三年开始时进入临床试验 符合FDA的所有要求。一旦获得批准，我们的临床合作者将成为 i-RxTherm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.