CAD-CAM Technology for Diabetic Footwear

描述(申请人提供)：超过15%的糖尿病患者会经历足部溃疡。足部溃疡在护理成本和工作效率损失方面都很昂贵。足部溃疡也是美国每年8万多例糖尿病患者截肢的主要原因。为了防止溃疡和截肢，高危患者必须终身穿着特殊的鞋，作为全面护理和自我护理计划的一部分。目前，治疗鞋的设计和制造在很大程度上是基于主观标准。成功的鞋子通常是由经验丰富的工匠制作的，而且往往需要多次迭代。已经进行了几次尝试，以将关键的鞋脚界面(鞋垫)的设计过程量化。这些产品似乎并不是特别成功，因为缺乏一个明确定义的算法来将患者属性转化为鞋垫设计。我们将为糖尿病高危患者开发一套完整的治疗鞋系统，其中将包括：数据收集；鞋垫设计的自动算法；制造的CAD-CAM系统；以及包括鞋底修改在内的鞋选择系统。最终产品还将包括提供者和患者教育的手段，以及促进适当护理和自我护理的产品。第一阶段初步研究表明，在足底压力、足部形状和足弓形状方面的数据采集取得了成功。已经开发了鞋号以及压力和形状数据与鞋模板对齐的算法。现在存在一种用于基于形状和压力数据在计算机屏幕上重复设计鞋垫修改的方法，并且现在可以使用CAD-CAM系统来碾磨虚拟设计的鞋垫。从治愈的患者中获得的数据集首次为确定鞋内压力溃疡阈值提供了指导。我们还通过利用该方法将一组神经性高危足的鞋内压力降低到阈值以下，证明了整个过程的可行性。我们现在看到了一条通向系统进一步自动化和考虑脚下其他“危险”区域的明确道路。

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.