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期SBIR提案描述了加速上市新器械的策略和工作计划，该新器械将为重大公共卫生问题（足部疼痛）提供基于证据的患者特异性解决方案。TrueContour（R）治疗鞋垫系统最初是为了预防糖尿病患者的前足损伤而设计的。我们建议进一步开发和扩展TrueContour（R）系统的核心元件的适用性，为其他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/足跟疼痛。TrueContour（R）技术用于解决其他常见的足部问题，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目前解决方案通常不足以解决的更广泛的临床重要足部问题，而且还将为系统的成功商业化提供机会，该系统有望满足重大未满足的医疗需求。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：第二阶段目标：A）完成TrueContour（R）RA足部矫形器的开发，以缓解RA引起的前足疼痛。B）完成TrueContour（R）PF足部矫形器的开发，以缓解PF引起的足跟疼痛。C）通过临床试验验证TrueContour（R）RA足部矫形器的有效性。D）通过临床测试验证TrueContour（R）PF足部矫形器的有效性。E）在高容量诊所测试站点安装扩展的TrueContour（R）治疗鞋垫系统;根据医生和患者的反馈改进和优化系统的可用性。