Advanced In-Shoe Orthotic Treatment for Foot Pain

先进的鞋内矫形治疗足部疼痛

• 批准号: 8588241
• 负责人: Timothy Hurley
• 金额: $ 53.78万
• 依托单位: DIAPEDIA, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8588241
• 关键词: Address; Area; Arts; Clinic; Complement; Custom; Data; Development; Devices; Diabetes Mellitus; Elements; Expert Systems; Feedback; Foot Pain; Foot Ulcer; Future; Grant; Health; Heel; Injury; Iowa; Legal patent; Literature; Marketing; Measurement; Measures; Medical; Metatarsalgia; Methods; National Institute of Diabetes and Digestive and Kidney Diseases; Neuropathy; Pain; Patients; Peripheral Nervous System Diseases; Phase; Plantar Fasciitis; Prevention; Process; Product R; Production; Property; Provider; Public Health; Rheumatoid Arthritis; Series; Shapes; Shoes; Site; Small Business Innovation Research Grant; Solutions; System; Technology; Testing; Therapeutic; TimeLine; Universities; Validation; Work; base; commercialization; design; diabetic; diabetic patient; early experience; evidence base; foot; innovation; orthotics; phase 1 study; pressure; public health relevance; research clinical testing; usability

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.

描述（由申请人提供）：本II阶段SBIR提案描述了一种策略和工作计划，以加速推销一种新设备，该设备将为重大公共健康问题提供基于证据的，特定于患者的解决方案：脚痛。 Truecontour（R）治疗鞋垫系统最初是为预防糖尿病中的前脚损伤而构想的。我们建议进一步开发和扩展Truecontour（R）系统的核心元素的适用性，以为其他两个临床上重要的领域提供高级脚踏矫正器：类风湿关节炎/前脚疼痛和足底筋膜炎/脚跟疼痛。 Truecontour（R）技术在解决其他常见的脚注投诉方面的应用将补充现有的糖尿病产品，并为脚步专业人员提供了一种全面的解决方案，以设计和制造自定义的脚踏矫正器。这项扩展不仅将解决当前解决方案通常不足的临床上重要的脚部问题，而且还将为成功商业化的系统提供机会，该系统准备满足巨大的未满足医疗需求。此外，这将是市场上唯一在被裁判文献中存在证据基础的系统。我们的工作计划将采用可靠的科学方法来实现矫形设计和验证，以实现以下目的：a）完成Truecontour（R）RA脚矫形器的发展，以缓解由RA引起的前脚疼痛。 b）完成Truecontour（R）PF脚矫形器的发展，以缓解由PF引起的脚跟疼痛。 c）通过临床测试验证Truecontour（R）RA脚矫形器的功效。 d）通过临床测试验证Truecontour（R）PF脚矫形器的功效。 e）将扩展的Truecontour（R）治疗鞋垫系统安装在大容量诊所Beta网站上；根据从业人员和患者的反馈来完善并优化系统的可用性。