Detecting Arch Instability in Charcot Neuropathy

检测夏科神经病中的足弓不稳定性

基本信息

批准号：
10010413
负责人：
Jim Wayne Crafton
金额：
$ 14.14万
依托单位：
INNOVATIVE SCIENTIFIC SOLUTIONS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-01 至 2021-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10010413
关键词：
Address Affect Algorithms Ankle Anterior Calibration Clinical Complication Complications of Diabetes Mellitus Data Collection Detection Developed Countries Development Diabetes Mellitus Diabetic Foot Disease Distal Early Diagnosis Evaluation Friction Gait Goals Head Heel Individual Left Measurement Measures Metatarsal bone structure Monitor Neuropathy Osteopathic Medicine Patients Pattern Performance Peripheral Nervous System Diseases Phase Physicians Polyneuropathy Population Prevalence Procedures Process Property Prothrombin Reporting Research Resolution Risk Risk Factors Shoes Skin Stress System Technology Testing Ulcer Universities Validation arthropathies base cohort diabetic diabetic patient foot high risk human subject in vivo indexing innovation new technology novel strategies pressure programs prototype sensor sensor technology shear stress success tool

项目摘要

Abstract Charcot neuropathy (CN) is a serious complication resulting from poorly controlled diabetes and peripheral neuropathy that leads to the collapse, and ultimately the breakdown, of the midfoot. Charcot occurs in approximately 0.08% of the general diabetic population, however the prevalence increases to 13% in high-risk diabetic patients [1,2] and even 35% in patients with polyneuropathy in industrialized countries [3]. In terms of treating CN patients, Chantelau et al. [7] described the “perils of procrastination” and showed the effects of early versus delayed detection of arch instability and collapse. The Cleveland State University (CSU) team recently identified an early detection concept for arch instability [8] using a platform system for plantar shear and pressure measurements produced by Innovative Scientific Solutions Inc. (ISSI). The study developed a metric (Sflatten) to quantify arch instability that compared posterior shear under the heel with the anterior shear under the first metatarsal head. Sflatten was significantly higher in neuropathic diabetics than in controls. Unfortunately, the platform system limited the evaluation to barefoot plantar contact patterns and a limited number of steps. Here we propose the next step in developing a tool for detecting and monitoring arch instability, specifically, an in-shoe system that measures plantar pressure and shear in normal footwear over multiple gait cycles. We believe that an in-shoe system will also facilitate clinical deployment. Phase I will combine CSU’s arch collapse detection algorithms with ISSI’s new in-shoe sensor technology. It will include benchtop calibration and validation of the in-shoe system and comprehensive gait testing with a cohort of control subjects with varying arch indices. If successful, Phase II will evaluate the system’s performance with diabetic and Charcot patients and develop risk thresholds. The overall objective is to lay the groundwork for commercializing a product that not only enables early diagnosis and monitoring of “Charcot foot”, but also addresses the broad need to assess risk factors for skin breakdown under the feet of diabetic patients.

抽象的 Charcot Neuropathy（CN）是由控制较差的糖尿病引起的严重并发症和周围神经病，导致崩溃，最终导致崩溃中足。 Charcot发生在大约0.08％的一般糖尿病人群中，但是高危糖尿病患者的患病率增加到13％[1,2]，甚至35％工业化国家的多发性神经病[3]。在治疗CN患者方面，Chantelau等。 [7]描述了“拖延的危险”，并显示了早期与延迟的影响检测拱形不稳定性和崩溃。克利夫兰州立大学（CSU）团队最近确定了一个早期检测概念对于拱形不稳定性[8]，使用平台系统进行足底剪切和压力测量由创新的科学解决方案公司（ISSI）生产。该研究开发了一个度量标准（Sflatten）量化拱形的不稳定性，该拱形在脚后跟下的后剪切与前剪切在第一个meta骨头下。神经性糖尿病患者的Sflatten明显高于控件。不幸的是，平台系统将评估限制为赤脚足底联系模式和有限数量的步骤。在这里，我们提出了开发一个工具的下一步检测和监测拱形不稳定性，特别是一种测量足底的靴子内系统在多个战斗周期上，正常鞋类的压力和剪切。我们相信一个鞋带系统还将促进临床部署。第一阶段将将CSU的拱门倒塌检测算法与ISSI的新鞋结合在一起传感器技术。它将包括台式校准和鞋内系统的验证具有不同拱形指数的控制对象的综合步态测试。如果成功的第二阶段将评估该系统的糖尿病患者的性能并发展风险阈值。总体目标是为商业化奠定基础不仅可以早期诊断和监视“ charcot脚”的产品，还可以解决了评估糖尿病脚下皮肤破裂风险因素的广泛需求患者。