Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure

据估计，在全球范围内，每30秒就发生一次下肢截肢， 这些截肢是糖尿病足溃疡的结果。足底溃疡的发展，部分是由于高 对足部软组织的负荷和机械应力。定制护理标准鞋垫旨在减少 通过将压力重新分配到其他区域而经历过度足底压力的足部区域。 然而，护理标准鞋垫的有效性的局限性导致了仍然存在的溃疡率。 不可接受的高。与此同时，3D打印技术、材料特性和数字化技术的革命也在不断发展。 制造管道正在推动一波创新解决方案，这些解决方案正在改善许多领域的成果。 医学领域。我们的目标是利用这些技术来创造新的患者特定的3D打印鞋垫 我们相信个性化的超材料将展示出上级卸载性能。 个性化的超材料是由来自患者的晶格图案形成的3D打印材料。 特殊的特性，从而使鞋垫能够与患者的需求独特地匹配。的目的 这项研究旨在确定带有个性化超材料的3D打印鞋垫是否能降低足底压力 对于足部的危险区域，比标准护理鞋垫更好。我们将生产三种不同的鞋垫， 即标准护理（SC）、基于3D打印压力（3DP-PB）和有限元优化 （3DP-FE）鞋垫。3DP-PB鞋垫将从足底形状和动态足底压力设计 而3DP-FE鞋垫将根据参与者的脚与不同的 鞋垫设计，以优化鞋垫形状和超材料性能。在一项重复测量研究中， 我们将测量每种鞋垫的峰值足底压力和压力时间积分， 25名患有糖尿病和前足压力升高的参与者。我们假设3D打印的 由来自足底测量的个性化超材料（3DP-PB）组成的鞋垫将具有 峰值足底压力和压力时间积分比SC内底（H1）的降低更大。 此外，我们假设，相对于其他两个鞋垫，鞋垫优化，通过病人- 特定的有限元模拟（3DP-FE）将最大程度地降低峰值足底压力， 压力时间积分（H2）。为了促进新型3D打印鞋垫的临床翻译，我们将携带 与患者和临床医生进行焦点小组讨论，以获得他们的早期反馈和见解。从这些 焦点小组将被定性地合成为对鞋垫的可操作改进。一种新型鞋垫 利用3D打印制造可以提供对足部溃疡的增强保护， 进展到截肢。此外，数字化制造技术和3D制造方法 大规模生产的障碍相对较低，这可以大大加快转化为诊所。退伍军人事务部是 被广泛认为是医疗保健创新的领导者。定制3D打印鞋垫的开发 这可能会降低截肢的风险是与VA的创新精神，并支持 退伍军人事务部的使命是“照顾那些应该承担战斗的人”。降低退伍军人的溃疡率 人口有潜力大大降低下肢截肢的发生率，提高质量 为我们的退伍军人。

It is estimated that, globally, a lower extremity amputation takes place every 30 seconds, and that 85% of these amputations are the result of diabetic foot ulcers. Plantar foot ulcers develop, in part, due to high loading and mechanical stress to the soft tissues of the foot. Custom standard of care insoles aim to reduce regions of the foot that experience excessive plantar pressures by redistributing pressure to other areas. Limitations in the effectiveness of standard of care insoles, however, result in rates of ulceration that remain unacceptably high. Meanwhile, a revolution in 3D printing technologies, material properties, and digital manufacturing pipelines are enabling a wave of innovative solutions that are improving outcomes in many areas of medicine. We aim to leverage these techniques to create novel patient-specific 3D printed insoles with personalized metamaterials which we believe will demonstrate superior offloading performance. Personalized metamaterials are 3D printed materials formed from lattice patterns derived from patient- specific characteristics, resulting in insoles that are uniquely matched to the patient’s needs. The aim of this study is to determine if 3D printed insoles with personalized metamaterials reduce plantar pressures for at-risk areas of the foot better than standard of care insoles. We will manufacture three different insoles, namely the standard of care (SC), 3D printed pressure based (3DP-PB), and finite element optimized (3DP-FE) insoles. 3DP-PB insoles will be designed from plantar foot shape and dynamic plantar pressure while the 3DP-FE insoles will be designed from simulations of participant’s feet interacting with different insole designs to optimize the insole shape and metamaterial properties. In a repeated measures study, we will measure peak plantar pressure and pressure time integral for each type of insole with a group of 25 participants who have diabetes and elevated forefoot pressure. We hypothesize that the 3D printed insoles comprised of personalized metamaterials derived from plantar measurements (3DP-PB) will have greater reductions in the peak plantar pressure and pressure time integral than the SC insoles (H1). Additionally, we hypothesize that, relative to the other two insoles, insoles optimized through patient- specific finite element simulations (3DP-FE) will have the greatest reduction in peak plantar pressure and pressure time integral (H2). To facilitate the clinical translation of the novel 3D printed insoles we will carry out focus groups with patients and clinicians to gain their early feedback and insights. Results from these focus groups will be qualitatively synthesized into actionable improvements to the insoles. Novel insoles that utilize 3D printing fabrication may provide enhanced protection from foot ulcers that frequently progress to amputation. Moreover, digital manufacturing technologies and 3D fabrication methods have relatively low barriers to mass production, which can greatly expedite translation into clinics. The VA is widely recognized as a leader in health care innovation. The development of custom 3D printed insoles that may reduce risk for amputation is well-aligned with VA’s spirit of innovation and is supported by the VA mission “To care for him who shall have borne the battle.” Reducing rates of ulceration in our Veteran population has the potential to greatly reduce incidence of lower-limb amputations and improve the quality of life for our Veterans.