Advanced In-Shoe Orthotic Treatment for Foot Pain

描述（由申请人提供）：DIApedia， LLC开发并科学验证了用于糖尿病患者治疗性鞋垫设计和生产的系统，TrueContour(R)治疗性鞋垫系统。在这项SBIR提案中，我们的目标是进一步开发和扩展TrueContour(R)系统核心元件的适用性，为另外两个临床重要领域提供先进的足部矫形器：类风湿关节炎（RA）引起的前脚疼痛和足底筋膜炎（PF）引起的脚跟疼痛。这里提出的第一阶段研究将证明这两个问题的概念。TrueContour(R)技术用于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的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往往不足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，该系统将填补重大的未满足医疗需求。如果第一阶段的努力取得成功，扩大的产品供应将通过内部实验，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士进行的beta测试进行严格评估-根据第二阶段的建议。具体目的：A)试点测试一系列足矫形器，其中包括患者特定的足底压力测量，旨在减少类风湿关节炎患者的前脚疼痛。B)试点测试一系列足部矫形器，该矫形器在干预设计中纳入了患者特定的足底压力测量，旨在减轻因足底筋膜炎引起的足跟疼痛患者的疼痛。第一阶段计划的成功实施将使DIApedia能够完成以下里程碑：对于类风湿性关节炎和前足疼痛的患者，将通过反复实验提出前足阈值压力轮廓、干预几何形状和材料特征，以便基于这些特征的干预（杆、垫、缓解）将提供疼痛缓解。2. 对于PF和足跟疼痛的患者，将通过反复实验提出足跟阈值压力轮廓、干预几何形状和材料特征，以便基于这些特征的干预将提供疼痛缓解。

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).