Non-invasive Monitoring of Perfusion in Diabetics

糖尿病患者灌注的无创监测

• 批准号: 6883635
• 负责人: GREGORY T MARTIN
• 金额: $ 16.82万
• 依托单位: THERMAL TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6883635
• 关键词: amputation; bioengineering /biomedical engineering; biological models; capillary; clinical biomedical equipment; computer assisted diagnosis; computer program /software; diabetes mellitus; diabetic neuropathy; diagnosis design /evaluation; early diagnosis; microcirculation; noninvasive diagnosis; patient monitoring device; peripheral blood vessel; swine; thermal blood flow measurement

DESCRIPTION (provided by applicant): Diabetics with neuropathy are at risk for limb loss due to amputation. Neuropathy and loss of sensation can lead to skin ulcerations that are slow to heal under conditions of low peripheral blood flow. Infection, gangrene and amputation are common occurrences. Early detection of the onset of vascular complications is a critical step in the optimal management of diabetic patients. We plan to develop a system (sensor, monitor and algorithms) that will enable the physician to non-invasively quantify the level of peripheral capillary blood flow in diabetics and anticipate vascular-related complications. The ability to non-invasively monitor peripheral capillary blood flow will: 1) provide an early warning of vascular complications; and 2) help manage therapies that address circulatory problems. The monitoring of peripheral blood flow will help prevent amputations. In the case where an amputation is indicated, quantitative knowledge of peripheral blood flow will help determine the optimal location of the amputation that preserves as much of the limb as possible and insures that the limb flap has adequate blood flow to heal. The goal of this project is the development of a non-invasive clinical device to monitor capillary blood flow. In Phase 1 we will develop a prototype system to quantify peripheral microcirculation using a thermal-based technique (Specific Aims 1 and 2) and we will test this system in the laboratory (Specific Aim 3) and in an animal model (Specific Aim 4). In Phase II, we will develop a beta system and conduct a clinical study to demonstrate the safety and efficacy of the non-invasive perfusion measurement in a diabetic population. The routine clinical use of this device will substantially reduce the need for amputations in diabetics.

描述(申请人提供)：有神经病变的糖尿病患者有因截肢而失去肢体的风险。神经病变和感觉丧失可导致皮肤溃疡，在外周血流量低的情况下愈合缓慢。感染、坏疽和截肢是常见的情况。早期发现血管并发症的发生是糖尿病患者最佳治疗的关键步骤。我们计划开发一种系统(传感器、监测器和算法)，使医生能够非侵入性地量化糖尿病患者的外周毛细血管血流水平，并预测与血管相关的并发症。非侵入性监测外周毛细血管血流的能力将：1)提供血管并发症的早期预警；2)帮助管理解决循环问题的治疗方法。监测外周血流将有助于防止截肢。在需要截肢的情况下，对周围血流量的定量了解将有助于确定截肢的最佳位置，尽可能多地保留肢体，并确保肢体皮瓣有足够的血流量来愈合。本项目的目标是开发一种非侵入性的临床设备来监测毛细血管血流。在第一阶段，我们将开发一个原型系统，使用基于热量的技术(特定目标1和2)来量化外周微循环，我们将在实验室(特定目标3)和动物模型(特定目标4)中测试该系统。在第二阶段，我们将开发一个Beta系统并进行临床研究，以证明非侵入性血流灌注测量在糖尿病人群中的安全性和有效性。这种设备的常规临床使用将大大减少糖尿病患者截肢的需要。