Commercialization of TrueContour® Custom Diabetic Foot Orthoses

TrueContour® 定制糖尿病足矫形器的商业化

• 批准号: 9345475
• 负责人: PETER Robert CAVANAGH
• 金额: $ 62.11万
• 依托单位: DIAPEDIA, LLC
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-06-15 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9345475
• 关键词: Address; Algorithm Design; Calibration; Clinic; Clinical; Clinical Research; Collaborations; Computer software; Computer-Aided Design; Custom; Data; Development; Diabetic Foot; Dimensions; Foot Ulcer; Funding; Goals; Head; Height; Measurement; Measures; Medicare; Modification; Neuropathy; Orthotic Devices; Output; Patients; Plantar Ulcers; Prevention; Prevention trial; Price; Process; Production; Provider; Recurrence; Resolution; Risk; Scanning; Shapes; Shoes; Site; Small Business Innovation Research Grant; Software Design; Surface; System; Testing; Therapeutic; Time; Ulcer; United States National Institutes of Health; Update; Vendor; Work; base; clinical efficacy; commercialization; cost; data acquisition; design; diabetic; diabetic patient; experience; field study; foot; improved; individual patient; interest; novel; pressure; programs; prototype; sensor; tool; virtual

Project Summary DIApedia, LLC, funded by the National Institutes of Health SBIR program, has developed an advanced diabetic foot orthosis system. DIApedia’s TrueContour® custom diabetic foot orthoses (CDFO) are designed by combining the patient’s unique foot shape with customized offloading modifications of the orthosis surface that are based on the patient’s unique measured plantar pressure. TrueContour® CDFOs have been clinically tested in head-to-head studies against diabetic shoe inserts currently approved by Medicare as “best practice” and have been shown to 1) operate differently by significantly reducing plantar pressure via precise placement of offloading orthosis modifications (Owings et al. 2008) and 2) provide significant therapeutic distinction in reducing ulceration by 3.4 fold in patients at elevated risk for development of a diabetic plantar ulcer (Ulbrecht et al. 2014). The proposed project will address the remaining key cost drivers in the commercial scale manufacturing and distribution of the TrueContour® CDFO. Specifically, improvements to the orthosis design process and development of lower cost foot pressure measurement hardware will enable DIApedia and its commercialization partner to introduce the TrueContour® CDFO product to the therapeutic footwear marketplace. For the first time, therapeutic footwear providers and their patients will have access to custom diabetic foot orthoses with demonstrated clinical efficacy in the prevention of foot ulcer recurrence. We will collaborate with our commercialization partner and other key vendors to execute our work plan which is focused on completion of the following late stage development activities: A) Create TrueContour® custom insole design functionality in a commercial CADCAM software application. B) Develop and test a low-cost, high resolution plantar pressure measurement system. C) Integrate TrueContour® CDFO with our commercial partner’s in-clinic patient data acquisition system.

项目摘要 DIApedia，LLC，由美国国立卫生研究院SBIR计划资助，开发了一种先进的 糖尿病足矫形器系统DIApedia的TrueContour®定制糖尿病足矫形器（CDFO） 通过将患者独特的足部形状与矫形器的定制卸载修改相结合 根据患者独特的足底压力测量，TrueContour® CDFO具有 在头对头研究中进行了临床测试，针对目前由医疗保险批准的糖尿病鞋插入物 作为“最佳实践”，并且已经显示出1）通过显著降低足底压力而不同地操作 通过精确放置卸载矫形器改良（Owings等人，2008）和2）提供显著的 在发生溃疡的风险升高的患者中将溃疡减少3.4倍的治疗差异 糖尿病足底溃疡（Ulbrecht等人，2014）。 拟议项目将解决商业规模生产中剩余的主要成本驱动因素 和TrueContour® CDFO的分销。具体而言，改进矫形器设计过程， 开发低成本的足部压力测量硬件将使DIApedia及其 将TrueContour® CDFO产品引入治疗鞋的商业化合作伙伴 市场。这是第一次，治疗鞋供应商和他们的病人将有机会获得定制的 糖尿病足矫形器在预防足部溃疡复发方面具有临床疗效。 我们将与我们的商业化合作伙伴和其他主要供应商合作，以执行我们的工作计划 其重点是完成以下后期开发活动： A）在商业CADCAM软件应用程序中创建TrueContour®定制鞋垫设计功能。 B）开发并测试低成本、高分辨率足底压力测量系统。 C）将TrueContour® CDFO与我们的商业合作伙伴的临床患者数据采集系统集成。