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

用于检测大纤维和小纤维糖尿病周围神经病变的热成像模式。

• 批准号: 10007575
• 负责人: David S Schade
• 金额: $ 98.91万
• 依托单位: VISIONQUEST BIOMEDICAL INC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10007575
• 关键词: Address; Affect; American; Amputation; Biopsy; Blood flow; Businesses; Center for Translational Science Activities; Centers for Disease Control and Prevention (U.S.); Clinic; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Complications of Diabetes Mellitus; Computer software; Data; Data Collection; Detection; Devices; Diabetes Mellitus; Diabetic Retinopathy; Diagnosis; Durable Medical Equipment; Early Diagnosis; Enrollment; Environment; Equipment Design; Feedback; Fiber; Funding; Goals; Grant; Image; Image Analysis; Intervention; Lead; Legal patent; Letters; Lower Extremity; Marketing; Measurement; Methods; Mexico; Mind; National Institute of Diabetes and Digestive and Kidney Diseases; Neurologic; Neurons; Neuropathy; New Mexico; Outcome; Patients; Performance; Peripheral Nervous System Diseases; Phase; Physicians; Physiologic Thermoregulation; Podiatry; Population; Privatization; Process; Protocols documentation; Public Health; Readiness; Recommendation; Reference Standards; Reporting; Reproducibility; Research; Sample Size; Scientist; Sensitivity and Specificity; Sensory; Series; Signal Transduction; Skin; Specificity; Stream; Structure; System; Technology; Testing; Time; United States; Universities; Validation; base; cohort; comorbidity; cost; design; design and construction; diabetic; diagnostic accuracy; early screening; effectiveness validation; experience; foot; imaging modality; improved outcome; innovation; interest; lepton; limb amputation; meetings; nerve conduction study; portability; power analysis; preclinical study; primary care setting; primary endpoint; prototype; research clinical testing; research study; safety testing; screening; software development; standard of care; statistics; success; tertiary care; tool

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.

概括 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 万美国人被报告患有 患有糖尿病，每年新诊断出 140 万糖尿病病例。至少50%的患者 糖尿病患者在一生中的某个时候会出现 DPN，高达 20% 的人在患病时患有 DPN 糖尿病诊断。 DPN 可导致 15% 的糖尿病患者足部或肢体截肢，其中 82,000 美国每年都会发生下肢截肢手术。因此，需要一种准确的检测手段 当进行干预时，早期 DPN 的存在对于改善结果至关重要 最有效。 VisionQuest Biomedical 组建了一个代表跨学科的合作者团队 一群在自动化热图像分析、糖尿病方面拥有丰富经验的科学家 合并症诊断和治疗，以及 DPN 和足病学专业研究。这支球队 将继续开发和测试 i-RxTherm ™，我们的专利设备，其原理是 皮肤血流量受多种受糖尿病影响的神经元因素调节， 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 集成了热像仪和 全自动热图像分析软件，可提高诊断准确性 DPN，导致目前被漏诊的 DPN 患者数量减少 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，这是目前其他单一设备不具备的功能，并且 这将使其成为医生 DPN 筛查的护理标准。 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 足部表现出优异的性能，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备投入商业化 通过产品化过程的路径，使其为筛选中的广泛使用做好准备。 在此项目结束时，i-RxTherm 将处于商业准备阶段，来自各方的兴趣 第三方投资者最大化。我们将通过以下具体工作来实现这些目标 目标：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（英国大学）进行非干预性测试 新墨西哥州临床与转化科学中心； 2) 进行临床研究以验证 商业 iRxTherm。该临床研究将招募一组 N = 336 名被诊断患有以下疾病的受试者 糖尿病。该样本量是根据统计功效分析确定的，以拒绝零值 我们的主要终点假设（敏感性/特异性<85%/75%）。 到资助的第 2 年结束时，i-RxTherm 将在第 3 年开始时进入临床试验 符合 FDA 的所有要求。一旦清除，我们的临床合作者将成为早期 i-RxTherm 的采用者，它将成为 DPN 筛查的标准。