Design Criteria for Therapeutic Footware in Diabetes

描述（由申请人提供）：糖尿病的足部并发症对公共健康产生不利影响。糖尿病患者足部溃疡的估计终生风险为25%;溃疡导致美国糖尿病患者每年80，000例下肢截肢中的大多数。每年的医疗保健费用总额为110亿美元，少数民族受到的影响尤其严重。神经病性糖尿病足的皮肤溃疡是由于足部和鞋之间的机械接触引起的，这种接触是患者感觉不到的。毫不奇怪，脚-鞋界面是研究的主要焦点。然而，为糖尿病患者设计治疗鞋仍然基于轶事;儿科医生的技能很少有科学数据。我们建议建立在我们成功应用于足部生物力学的有限元（FE）方法（授权5 R 01 HD 037433）的基础上。我们将为设计治疗鞋垫提供指导，并探索针对患者的建模技术。在特定目标1中，我们将使用3D患者特定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灶性压力的不同足型中缓解足底压力。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”，允许配置更改。在验证阶段，我们将直接比较测量的足底压力与预测的足底压力，包括平坦鞋垫与贴合鞋垫、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。在具体目标2中，我们将研究基于压力测量值对具有单个或多个足底压力升高区域的危险足部进行建模的可行性。我们将根据人体测量数据和来自超声的组织厚度测量值，通过对特定目标1的FE网格进行“变形”来开发患者特定模型。在具体目标3中，我们将使用多功能治疗鞋垫模型，用于高危足部（例如，跖骨垫，酒吧，改变足弓支持，并在个别MTH下的材料深度的变化），将使用鞋内压力1测量进行验证。这些实验和模拟应该导致（a）一组治疗鞋垫设计的一般规则和（B）在复杂情况下用于患者特定建模的工具。如果下肢溃疡可以在导致截肢之前预防，美国将在患者生活质量方面节省大量成本，并减少长期康复的需要，以及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.