Foot Pressure and Shear Data Visualization System

描述(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导致超过10亿美元的医疗费用。这一多方面的问题涉及足底软组织对施加在表皮上的外力和内部变化(如血管供应和神经病变)的反应。越来越多的证据表明，外力升高(压力和剪切)和组织特性改变的组合在足部溃疡的病因中是最重要的。这项研究的总体目标是开发一个软件包，使临床医生能够准确地显示足底表面的三维(3-D)压力和剪切模式，并确定关注的区域。该软件适用于各种测量系统，使用创新技术同时显示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。已经创建了分析算法，以确定最可能对皮肤造成病理后果的压力和压力模式的位置和大小。整形外科专家已经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。在这些成果的基础上，第二阶段的工作将集中于开发一套完整的足部压力和剪切数据可视化和分析软件系统。任务包括设计灵活的数据模型、广泛的自动化分析工具套件、全面、易于使用的图形用户界面，以及在适合商业化的模块化软件体系结构中实施这些功能，作为交钥匙系统或集成到传感器供应商现有软件中的模块。其他第二阶段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结合使用。与监测垂直压力和水平剪切力的新一代测量系统相结合，该软件将成为研究足部溃疡病因和糖尿病患者风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.