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.

抽象的夏科神经病 (CN) 是糖尿病控制不佳导致的严重并发症和周围神经病变，导致崩溃并最终崩溃大约 0.08% 的普通糖尿病人群中存在夏科病，但高危糖尿病患者的患病率增至 13% [1,2]，糖尿病患者的患病率甚至增至 35% 工业化国家的多发性神经病 [3] 在治疗 CN 患者方面，Chantelau 等人。 [7] 描述了“拖延的危险”，并展示了提前与延迟的影响检测拱门失稳和倒塌。克利夫兰州立大学 (CSU) 团队最近确定了一个早期检测概念针对足弓不稳定性 [8] 使用平台系统进行足底剪切和压力测量由 Innovative Scientific Solutions Inc. (ISSI) 制作该研究开发了一个指标 (Sflatten)。量化足弓不稳定性，比较脚后跟下方的后剪切力和前剪切力神经性糖尿病患者第一跖骨头下的 Sflatten 显着高于糖尿病患者。不幸的是，平台系统将评估限制为赤脚足底接触。在这里，我们提出了开发工具的下一步。检测和监控足弓不稳定性，特别是测量足底的鞋内系统我们认为，正常鞋类在多个步态周期中的压力和剪切力。系统还将促进临床部署。第一阶段将把 CSU 的足弓塌陷检测算法与 ISSI 的新型鞋内算法相结合它将包括鞋内系统的台式校准和验证以及对一组具有不同足弓指数的对照受试者进行全面的步态测试。成功后，第二阶段将评估该系统在糖尿病和夏科患者中的性能并制定风险阈值，为商业化奠定基础。该产品不仅可以实现“夏科足”的早期诊断和监测，还可以满足评估糖尿病患者脚下皮肤破损风险因素的广泛需求患者。