Advanced In-Shoe Orthotic Treatment for Foot Pain

先进的鞋内矫形治疗足部疼痛

• 批准号: 8199959
• 负责人: Timothy Hurley
• 金额: $ 14.12万
• 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 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8199959
• 关键词: Address; Algorithms; Area; Characteristics; Clinical; Collection; Complement; Custom; Data; Development; Elements; Foot Pain; Foot Ulcer; Future; Goals; Grant; Health; Healthcare; Heel; Industry; Intervention; Iowa; Lead; Manufacturer Name; Marketing; Measurement; Medical; Metatarsalgia; National Institute of Diabetes and Digestive and Kidney Diseases; Neuropathy; Orthopedics; Orthotic Devices; Pain; Patients; Penetration; Peripheral Nervous System Diseases; Phase; Plantar Fasciitis; Population; Production; Provider; Research; Rheumatoid Arthritis; Series; Shapes; Shoes; Small Business Innovation Research Grant; Solutions; System; Technology; Testing; Therapeutic; Universities; Validation; base; commercialization; design; diabetic; diabetic patient; early experience; foot; high risk; improved; orthotics; phase 1 study; pressure; research study; standard of care; therapy design; tool

DESCRIPTION (provided by applicant): DIApedia, LLC has developed and scientifically validated a system for the design and production of therapeutic insoles for diabetic patients, the TrueContour(R) therapeutic insole system. In this SBIR proposal we aim 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: forefoot pain due to rheumatoid arthritis (RA) and heel pain due to plantar fasciitis (PF). The Phase I studies proposed here will be proof of concept for these two problems. 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. If our Phase I efforts are successful, the expanded product offering would be rigorously evaluated through internal experimentation, independent validation with research collaborators and beta testing by professionals in the podiatric, rheumatologic, and orthopedic fields - under a Phase II proposal. Specific Aims: A) Pilot-test a line of foot orthotics which incorporates patient-specific plantar pressure measurements in the design of interventions aimed at reducing forefoot pain for people with rheumatoid arthritis. B) Pilot-test a line of foot orthotics which incorporates patient-specific plantar pressure measurements in the design of interventions aimed at reducing pain for people with heel pain due to plantar fasciitis. Successful execution of the Phase I plan will enable DIApedia to accomplish the following milestones: 1. In patients with RA and forefoot pain, a forefoot threshold pressure contour and intervention geometry and material characteristics will be suggested by iterative experiments such that interventions (bars, pads, reliefs) based on these characteristics will provide pain relief. 2. In patients with PF and heel pain, a heel threshold pressure contour and intervention geometry and material characteristics will be suggested by iterative experiments such that interventions based on these characteristics will provide pain relief. PUBLIC HEALTH RELEVANCE: DIApedia, LLC has developed and scientifically validated a system for the design and production of therapeutic insoles for diabetic patients, the TrueContour(R) therapeutic insole system. In this SBIR proposal we aim 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: forefoot pain due to rheumatoid arthritis (RA) and heel pain due to plantar fasciitis (PF).

描述（由申请人提供）：DIApedia, LLC 开发并科学验证了一种用于设计和生产糖尿病患者治疗鞋垫的系统，即 TrueContour(R) 治疗鞋垫系统。在此 SBIR 提案中，我们的目标是进一步开发和扩展 TrueContour(R) 系统核心要素的适用性，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 (RA) 引起的前足疼痛和类风湿性关节炎 (RA) 引起的足跟疼痛足底筋膜炎（PF）。这里提出的第一阶段研究将证明这两个问题的概念。应用 TrueContour(R) 技术解决其他常见足部不适问题将补充现有的糖尿病产品，并为足部专业人士提供设计和制造定制足部矫形器的全面解决方案。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），而且还将为系统的成功商业化提供机会，该系统有望满足重大的未满足的医疗需求。如果我们的第一阶段工作取得成功，扩展后的产品将根据第二阶段提案，通过内部实验、与研究合作者的独立验证以及由足病、风湿病和骨科领域的专业人员进行的 beta 测试进行严格评估。具体目标：A) 对一系列足部矫形器进行试点测试，该矫形器将患者特定的足底压力测量纳入干预措施的设计中，旨在减轻类风湿性关节炎患者的前足疼痛。 B) 对一系列足部矫形器进行试点测试，该矫形器将患者特定的足底压力测量纳入干预措施的设计中，旨在减轻足底筋膜炎引起的足跟痛患者的疼痛。第一阶段计划的成功执行将使 DIApedia 能够实现以下里程碑： 1. 对于患有 RA 和前足疼痛的患者，将通过迭代实验建议前足阈值压力轮廓和干预几何形状以及材料特性，以便干预措施（杆、垫） 、缓解）基于这些特征将提供疼痛缓解。 2. 对于患有 PF 和足跟疼痛的患者，将通过迭代实验建议足跟阈值压力轮廓以及干预几何形状和材料特性，以便基于这些特性的干预措施将缓解疼痛。 公共健康相关性：DIApedia, LLC 开发并科学验证了一种用于糖尿病患者治疗鞋垫设计和生产的系统，即 TrueContour(R) 治疗鞋垫系统。在此 SBIR 提案中，我们的目标是进一步开发和扩展 TrueContour(R) 系统核心要素的适用性，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 (RA) 引起的前足疼痛和类风湿性关节炎 (RA) 引起的足跟疼痛足底筋膜炎（PF）。