Commercialization of TrueContour® Custom Diabetic Foot Orthoses

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TrueConour®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 根据患者独特测量的足底压力来测量体表压力。TrueConour®CDFO具有 在与目前获得联邦医疗保险批准的糖尿病鞋植入物进行的面对面研究中进行了临床测试 作为“最佳实践”，并已被证明1)通过显著降低足底压力而以不同的方式运作 通过精确放置卸载矫形器改进(Owins等人2008)和2)提供显著 在将溃疡减少3.4倍的治疗差异中，高危患者发展为 糖尿病足底溃疡(Ulbrecht et al.2014年)。 拟议的项目将解决商业规模制造中剩余的关键成本驱动因素 和分发TrueConour®CDFO。具体地说，对矫形器设计流程和 低成本足底压力测量硬件的开发将使DIApedia及其 商业化合作伙伴将TrueConour®CDFO产品引入治疗鞋 集市。第一次，治疗鞋供应商和他们的患者将可以进入定制 糖尿病足矫形器在预防足部溃疡复发中的临床疗效。 我们将与商业化合作伙伴和其他主要供应商合作，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TrueConour®定制鞋垫设计功能。 B)开发和测试低成本、高分辨率的足底压力测量系统。 C)将TrueConour®CDFO与我们的商业合作伙伴的门诊患者数据采集系统集成。

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.