Non-invasive Monitoring of Perfusion in Diabetics

描述（由申请人提供）：伴有神经病变的糖尿病患者有截肢导致肢体丧失的风险。神经病变和感觉丧失可导致皮肤溃疡，在低外周血流量的情况下愈合缓慢。感染、坏疽和截肢是常见的。血管并发症的早期发现是糖尿病患者最佳治疗的关键一步。我们计划开发一种系统（传感器、监视器和算法），使医生能够无创地量化糖尿病患者外周血管血流水平，并预测血管相关并发症。无创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)帮助管理针对循环系统问题的治疗方法。监测外周血流量有助于防止截肢。在需要截肢的情况下，对外周血流量的定量了解将有助于确定截肢的最佳位置，以尽可能多地保留肢体，并确保肢体皮瓣有足够的血流来愈合。该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II期，我们将开发一个beta系统并进行临床研究，以证明非侵入性灌注测量在糖尿病人群中的安全性和有效性。该装置的常规临床使用将大大减少糖尿病患者截肢的需要。

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.