Advanced In-Shoe Orthotic Treatment for Foot Pain

描述(由申请人提供)：这份第二阶段的SBIR提案描述了一项战略和工作计划，以加速一种新设备的上市，该设备将为脚痛这一重大公共健康问题提供基于证据的、针对患者的解决方案。TrueConour(R)治疗性鞋垫系统最初是为预防糖尿病患者的前脚损伤而设计的。我们建议进一步开发和扩大TrueConour(R)系统的核心要素的适用性，以便为另外两个临床重要领域提供先进的足部矫形器：类风湿性关节炎/前足疼痛和足底筋膜炎/脚跟疼痛。应用TrueConour(R)技术来解决其他常见的足部疾病将补充现有的糖尿病产品，并为足部专业人员提供定制足部矫形器设计和制造的全面解决方案。这一扩展不仅将解决更广泛的临床重要足部问题，目前的解决方案往往不足以解决这些问题，而且还将为准备满足重大未得到满足的医疗需求的系统成功商业化提供机会。此外，这将是市场上唯一一个在参考文献中存在证据基础的系统。我们的工作计划将采用经过验证的科学方法进行矫形器设计和验证，以实现以下目标：a)完成TrueConour(R)RA足部矫形器的开发，以缓解由RA引起的前足疼痛。B)完成TrueConour(R)PF足部矫形器的开发，以缓解PF引起的脚后跟疼痛。C)通过临床测试验证TrueConour(R)RA足部矫形器的疗效。D)通过临床测试验证TrueConour(R)PF足部矫形器的疗效。E)在大量诊所的测试站点安装扩展的TrueConour(R)治疗鞋垫系统；根据从业者和患者的反馈改进和优化系统的可用性。

DESCRIPTION (provided by applicant): This Phase II SBIR proposal describes a strategy and work plan for accelerating to market a new device that will provide an evidence-based, patient-specific solution to a significant public health problem: foot pain. The TrueContour(R) therapeutic insole system was originally conceived for prevention of forefoot injury in diabetes mellitus. We propose to further develop and extend the applicability of the core elements of the TrueContour(R) system to provide advanced foot orthotics for two other clinically important areas: rheumatoid arthritis/forefoot pain and plantar fasciitis/heel pain. The application of the TrueContour(R) technology to address other common foot complaints will complement the existing diabetic product and offer foot professionals a comprehensive solution for the design and fabrication of custom foot orthotics. This extension will not only address a broader range of clinically important foot problems for which current solutions are often inadequate, but will also provide the opportunity for successful commercialization of a system that is poised to fill a significant unmet medical need. Furthermore, this will be the only system in the marketplace for which an evidence base exists in the refereed literature. Our work plan will employ a proven scientific approach for orthotic design and validation to achieve the following: Phase II Objectives: A) Complete the development of the TrueContour(R)RA foot orthotics for relief of forefoot pain caused by RA. B) Complete the development of the TrueContour(R)PF foot orthotics for relief of heel pain caused by PF. C) Validate the efficacy of the TrueContour(R)RA foot orthotics through clinical testing. D) Validate the efficacy of the TrueContour(R)PF foot orthotics through clinical testing. E) Install the expanded TrueContour(R) therapeutic insole system in high-volume clinics beta sites; refine and optimize usability of the system based upon practitioner and patient feedback.