Foot Pressure and Shear Data Visualization System

描述（由申请人提供）：足部溃疡是一种糖尿病并发症，估计仅在美国每年就造成超过10亿美元的医疗费用。这个多方面的问题涉及到足底软组织对施加于表皮的外力和内部变化（如血管供应和神经病变）的反应。越来越多的证据表明，外力（压力和剪切）升高和组织特性改变的结合在足部溃疡的病因学中是最重要的。这项研究的总体目标是开发一个软件包，使临床医生能够看到足底表面三维（3-D）压力和剪切模式的准确表示，并确定关注的区域。该软件适用于各种测量系统，采用创新技术同时可视化水平剪切和垂直压力。用户选项可用于增强可视化。第一阶段的结果表明，可视化方法和原型软件可以清楚地显示剪切和压力以及两者之间的关系。分析算法已经被创造出来，可以识别出最有可能导致皮肤病理后果的压力和压力模式的位置和大小。骨科专家使用来自实验传感器阵列的基线数据和相同格式的模拟数据对该软件进行了评估，并就其实用性提供了积极的反馈。基于这些成果，第二阶段的工作将侧重于开发一个完整的足部压力和剪切数据可视化和分析软件系统。任务包括设计一个灵活的数据模型，一套广泛的自动化分析工具，一个全面的，易于使用的图形用户界面，以及在模块化软件架构中实现这些功能，适合作为交钥匙系统商业化或集成在传感器供应商现有软件中的模块。第二阶段的其他活动包括与一个或多个硬件供应商订立许可证安排，以便将软件与其系统一起使用。结合监测垂直压力和水平剪切力的新一代测量系统，该软件将成为研究足部溃疡病因和糖尿病患者危险因素临床评估的关键工具。

DESCRIPTION (provided by applicant): Foot ulceration is a diabetic complication estimated to result in over $1 billion worth of medical expenses per year in the United States alone. This multifaceted problem involves the response of plantar soft tissue to both external forces applied to the epidermis and internal changes such as vascular supply and neuropathy. Increasing evidence indicates that a combination of elevated external forces (pressure and shear) and altered tissue properties is of prime importance in the etiology of foot ulcers. The overall goal of this research is to develop a software package that will allow a clinician to see an accurate representation of three-dimensional (3-D) pressure and shear patterns on the plantar surface and identify areas of concern. Adaptable to a variety of measurement systems, the software uses innovative techniques to simultaneously visualize horizontal shear and vertical pressure. User options are available to enhance the visualization. Phase I results demonstrated that the visualization approach and prototype software can provide clear indication of both shear and pressure and the relationship between the two. Analysis algorithms have been created that identify location and magnitude of patterns of pressure and stress most likely to cause, pathological consequences to the skin. Orthopedic specialists have evaluated the software using baseline data from an experimental sensor array and simulated data in the same format and provided positive feedback regarding its utility. Based on these achievements, the Phase II work will focus on development of a complete software system for foot pressure and shear data visualization and analysis. Tasks include design of a flexible data model, an extensive suite of automated analysis tools, a comprehensive, easy-to use graphical user interface, and implementation of these features in a modular software architecture suitable for commercialization as either a turnkey system or a module for integration in a sensor vendor's existing software. Other Phase II activities include the establishment of licensing arrangements with one or more hardware vendors to use the software in conjunction with their systems. In conjunction with a new generation of measurement systems that monitor vertical pressure and horizontal shear forces, this software will emerge as a key tool for research in the etiology of foot ulcers and clinical evaluation of risk factors in diabetic patients.