Visualizing Diabetic Feet to Optimize Orthotic Fitting

描述(申请人提供)：患有糖尿病(DM)和周围神经病变的人，由于步行过程中脚底反复受伤(足底压力)，皮肤破裂和随后的下肢截肢的风险很高。目前的康复方法使用主观方法制作治疗鞋，试图减少足底压力和防止皮肤破裂，但溃疡复发率很高(30%-57%)。该项目的长期目标是通过设计和制造基于糖尿病足的结构、组织力学和外部应力的矫形器来减少皮肤破裂和随后截肢的发生率。这项建议将利用有效和互补的研究设计，使用相同的患者和许多相同的措施在目标1中进行实验测试，并在目标2中开发和验证三维计算建模方法。目标1的目标是确定全接触垫(TCI)、足底垫和足垫放置对前足足底压力和软组织变形的影响。将鞋内压力测试与螺旋X射线计算机断层扫描(SXCT)相结合，不仅可以表明矫形器是否在降低前足压力方面有效，而且还可以说明矫形器为什么有效。目标2的目标是开发和验证三维计算模型，以评估糖尿病足矫形器对足底峰值压力和组织变形的影响。来自SXCT扫描的结构数据、材料特性(足底软组织和矫形器)以及糖尿病患者和周围神经病变患者的外部足底压力数据将结合在一起，开发和验证三维计算模型和方法。经过验证的模型将用于预测整个接触嵌体和跖垫的最佳特性(即材料特性、大小和位置)。预测的矫形器将在一组新的患者中与目标1中描述的传统矫形器进行测试，以测试其均匀分配前足足底压力的能力。实验测试将有助于保持计算模型的真实感和有效性，而三维计算建模将增强矫形器设计和测试的科学基础。

DESCRIPTION (provided by applicant): People with Diabetes Mellitus (DM) and peripheral neuropathy are at high risk for skin breakdown and subsequent lower extremity amputation due to unnoticed, repeated trauma (plantar pressures) to the plantar foot during walking. Current rehabilitation methods use subjective methods to fabricate therapeutic footwear m attempts to reduce plantar pressures and prevent skin breakdown, but ulcer recurrence is high (30-57%). The long term goal of this project is to reduce the incidence of skin breakdown and subsequent amputation by designing and fabricating orthotic devices based on structure, tissue mechanics, and external stresses of the diabetic foot. This proposal will capitalize on an efficient and complementary research design that uses the same patients and many of the same measures to conduct experimental testing in Aim 1 and to develop and validate three-dimensional computational modeling methods in Aim 2. The goal of Aim 1 is to determine the effect of a total contact insert (TCI), a metatarsal pad, and metatarsal pad placement on forefoot plantar pressures and soft tissue deformation. Combining in-shoe pressure testing with spiral x-ray computed tomography (SXCT) will indicate not only if the orthotic device is effective in reducing forefoot pressures, but also why the orthotic device is effective. The goal of Aim 2 is to develop and validate three-dimensional computational models for estimating the effects of diabetic foot orthoses on peak plantar pressure and tissue deformation. Structural data from SXCT scans, material properties (plantar soft tissue and orthotic device), and external plantar pressure data from people with DM and peripheral neuropathy will be combined to develop and validate the three-dimensional computational model and methods. The validated model will be used to predict optimal characteristics of the total contact insert and metatarsal pad (i.e. material properties, size, and placement). The predicted orthotic device will be tested against the traditional orthotic device described in Aim 1 in a new set of patients for its ability to distribute forefoot plantar pressures evenly. Experimental testing will help to keep computational models realistic and valid while three dimensional computational modeling will enhance the scientific basis of orthotic design and testing.