CAD-CAM Technology for Diabetic Footwear

适用于糖尿病鞋类的 CAD-CAM 技术

• 批准号: 6938501
• 负责人: JOSEPH L LOOMIS
• 金额: $ 55.38万
• 依托单位: DIAPEDIA, LLC
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-06-15 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6938501
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; clinical research; computer program /software; computer system design /evaluation; diabetes mellitus; diabetic neuropathy; foot; human subject

DESCRIPTION (provided by applicant): Over 15% of diabetic patients will experience a foot ulcer. Foot ulcers are expensive both in terms of cost of care and work productivity lost. Foot ulcers are also the dominant contributory cause to the more than 80,000 amputations performed in the US each year in diabetic patients. In order to prevent ulcerations and amputations, at-risk patients must use special footwear for life as part of a comprehensive care and self-care program. Currently the design and manufacture of therapeutic footwear is largely based on subjective criteria. Successful shoes are usually made by experienced craftspeople and much iteration is often required. Several attempts have been made to put the design process for the critical shoe-foot interface (insole) on a quantitative basis. These products appear to have not been particularly successful because of the lack of a well-defined algorithm to translate patient attributes into insole design. We will develop an entire therapeutic shoe system for at risk DM patients that will incorporate: data collection; automatic algorithm for insole design; CAD-CAM system for manufacture; and system for shoe selection including outsole modifications. The final product will also include a means for provider and patient education and products to promote appropriate care and self-care. Phase I preliminary studies have demonstrated success in data acquisition in the areas of plantar pressure, foot shape and arch shape. Algorithms for shoe sizing and alignment of the pressure and shape data with the shoe template have been developed. A method for reproducible design of insole modifications on the computer screen, based on the shape and pressure data, now exists and virtually designed insoles can now be milled using the CAD-CAM system. A data set from patients staying healed has been acquired that for the first time provides guidance for the identification of an in-shoe pressure ulceration threshold. We have also demonstrated feasibility of the whole process by utilizing the method to reduce in-shoe pressure below threshold in a group of neuropathic high-risk feet with high pressure at the first metatarsal head. We now see a clear path toward further automation of the system and to a consideration of other "at-risk" regions of the foot.

描述（由申请人提供）：超过15％的糖尿病患者会出现溃疡。在护理成本方面，脚步溃疡都很昂贵，并且失去了工作效率。脚溃疡也是糖尿病患者每年在美国进行的80,000多次截肢的主要因素。为了防止溃疡和截肢，高危患者必须使用特殊的鞋类作为综合护理和自我护理计划的一部分。目前，治疗鞋类的设计和制造主要基于主观标准。成功的鞋子通常是由经验丰富的工匠制作的，通常需要很多迭代。已经进行了几项尝试，以定量为关键的鞋子界面（鞋垫）的设计过程。由于缺乏将患者属性转化为鞋垫设计，这些产品似乎并不是特别成功。我们将为AT风险DM患者开发整个治疗鞋系统：数据收集；用于鞋垫设计的自动算法； CAD-CAM制造系统；和用于鞋子选择的系统，包括外底修改。最终产品还将包括提供者，患者教育和产品以促进适当的护理和自我保健的方法。第一阶段的初步研究表明，在足底压力，脚形和拱形形状领域的数据采集方面取得了成功。已经开发了用于鞋尺寸的算法以及压力和形状数据与鞋类模板的对齐的算法。基于形状和压力数据的计算机屏幕上可再现设计修改的方法，现在可以使用CAD-CAM系统铣削几乎设计的鞋垫。已经获得了住院治愈的患者的数据集，该数据首次为识别鞋管内压力溃疡阈值提供指导。我们还通过利用该方法将脚轮内压力降低到阈值的一组神经性高风险脚以高压在第一个meta骨头部的高压下方的阈值来证明了整个过程的可行性。现在，我们看到了通往系统进一步自动化的清晰途径，并考虑了脚的其他“处于危险”区域的考虑。