Design Criteria for Therapeutic Footware in Diabetes

描述（由申请人提供）：糖尿病足部并发症对公众健康产生不利影响。糖尿病患者患足部溃疡的估计终生风险为25%；美国每年有8万例糖尿病患者下肢截肢，其中大部分是溃疡造成的。医疗保健费用每年总计110亿美元，少数族裔受到的影响尤为严重。神经病变糖尿病足的皮肤溃疡是由足和鞋之间的机械接触引起的，而这种接触是患者无法感觉到的。不出所料，脚-鞋界面是研究的主要焦点。然而，糖尿病患者治疗鞋的设计仍然基于轶事；土壤学家的技能很少得到科学数据的证实。我们建议将我们成功应用的有限元（FE）方法应用于足部生物力学（授权5R01 HD037433）。我们将为设计治疗性鞋垫提供指导，并探索针对患者的建模技术。在具体目标1中，我们将使用3D患者特异性FE模型，定义鞋垫设计的一般原则，以确保在没有明显畸形或异常局压的不同足型中缓解足底压力。为了模拟结构/功能，我们的新型优化技术将帮助定义模型的“加载状态”，允许配置更改。在验证阶段，我们将直接比较测量和预测的鞋底压力，包括平底鞋垫与标准鞋垫、多层鞋垫与单层鞋垫、不同的鞋垫厚度，以及用于初级预防的不同鞋垫材料性能。在具体目标2中，我们将研究基于压力测量的单个或多个足底压力升高区域建模风险足的可行性。我们将根据人体测量数据和超声获得的组织厚度测量数据，通过“变形”来自Specific Aim 1的FE网格来开发患者特异性模型。在具体目标3中，我们将使用针对高危足部的多功能治疗性鞋垫模型（例如，跖垫、鞋棒、改变的足弓支撑以及不同MTHs下材料深度的变化），这些模型将通过鞋内压力测量1进行验证。这些实验和模拟应该导致(a)一套治疗性鞋垫设计的一般规则和(b)复杂情况下患者特定建模的工具。如果下肢溃疡能够在导致截肢之前得到预防，美国将在患者生活质量方面节省大量成本，减少长期康复的需要，减少随之而来的精神和身体痛苦。

DESCRIPTION (provided by applicant): Foot complications of diabetes adversely affect public health. Estimated lifetime risk of foot ulcers in diabetic patients is 25%; ulcers cause most of the 80,000 lower-extremity amputations in U.S. diabetic patients annually. Health-care costs total $11 billion per year, with minorities disproportionately affected. Skin ulceration in neuropathic diabetic feet arises from mechanical contact between the foot and shoe that such patients cannot feel. Unsurprisingly, the foot-shoe interface is a prime focus of study. However, design of therapeutic footwear for diabetic patients remains based on anecdote; pedorthists' skills are rarely informed by scientific data. We propose to build on our successfully applied finite element (FE) method to foot biomechanics (grant 5R01 HD037433). We will provide guidance for designing therapeutic insoles and explore techniques for patient-specific modeling. In Specific Aim 1, using 3D patient-specific FE models, we will define general principles for insole design to ensure plantar pressure relief in different foot types of those without significant deformity or abnormal focal pressure. To simulate structure/function, our novel optimization technique will help define a "loading state" for the model, allowing configuration change. In the validation phase, we will directly compare measured with predicted plantar pressures in flat vs. conforming insoles, multi-layers vs. single layers, varying insole thicknesses, and differing insole material properties available for primary prevention. In Specific Aim 2, we will examine the feasibility of modeling at-risk feet with single or multiple regions of elevated plantar pressure based on pressure measurements. We will develop patient-specific models obtained by "morphing" the FE meshes from Specific Aim 1, based on anthropometric data and tissue-thickness measurements derived from ultrasound. In Specific Aim 3, we will use models of multi-featured therapeutic insoles for at-risk feet (e.g., metatarsal pads, bars, altered arch supports, and variations in material depth under individual MTHs) that will be validated using in-shoe pressure1 measurements. These experiments and simulations should lead to (a) a set of general rules for therapeutic insole design and (b) a tool for patient-specific modeling in complex cases. If lower-extremity ulcers can be prevented before they lead to amputation, the U.S. will realize substantial cost savings in terms of patient quality of life and less need for lengthy rehabilitation, with its associated mental and physical suffering.