Design Criteria for Therapeutic Footware in Diabetes

描述(申请人提供)：糖尿病足部并发症对公众健康有不利影响。据估计，糖尿病患者一生中患足部溃疡的风险为25%；美国糖尿病患者每年8万例下肢截肢手术中，溃疡是主要原因。医疗保健费用每年总计110亿美元，少数族裔受到的影响不成比例。神经性糖尿病足的皮肤溃疡是由于脚和鞋之间的机械接触造成的，而这些患者感觉不到。不出所料，脚-鞋界面是研究的主要焦点。然而，针对糖尿病患者的治疗鞋的设计仍然基于轶事；儿科医生的技能很少得到科学数据的指导。我们建议在我们成功应用于足部生物力学的有限元(FE)方法的基础上(授予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，使用针对患者的三维有限元模型，我们将定义鞋垫设计的一般原则，以确保没有明显畸形或局部异常压力的不同足部类型的足底压力减轻。为了模拟结构/功能，我们的新优化技术将帮助定义模型的“加载状态”，允许更改配置。在验证阶段，我们将直接比较平底与符合鞋垫、多层鞋垫与单层鞋垫、不同鞋垫厚度以及可用于一级预防的不同鞋垫材料特性下的预测足底压力。在具体目标2中，我们将研究基于压力测量的具有单个或多个足底压力升高区域的高危足部建模的可行性。我们将根据人体测量数据和超声得出的组织厚度测量数据，通过对来自特定目标1的FE网格进行变形来开发特定于患者的模型。在具体目标3中，我们将使用用于高危足部的多功能治疗鞋垫的模型(例如，趾垫、横杆、改变的足弓支撑，以及个别月度下材料深度的变化)，这些模型将通过鞋内压力测量进行验证。这些实验和模拟将导致(A)一套治疗性鞋垫设计的一般规则和(B)用于复杂病例中患者特定建模的工具。如果能够在导致截肢之前预防下肢溃疡，美国将在患者生活质量方面实现大幅成本节约，并减少对长期康复的需求，以及与之相关的精神和身体痛苦。

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.