Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure

据估计，在全球范围内，每30秒就会发生一次下肢截肢，85%的 这些截肢是糖尿病足溃疡的结果。足底溃疡的发生，部分是由于高 对足部软组织的负荷和机械应力。定制护理鞋垫标准旨在减少 通过将压力重新分配到其他区域而使脚底压力过大的足部区域。 然而，标准护理鞋垫的有效性有限，导致溃烂率仍然存在 高得令人无法接受。与此同时，3D打印技术、材料特性和数字技术的革命 制造管道正在推动一波创新解决方案的浪潮，这些解决方案正在改善许多 医学领域。我们的目标是利用这些技术来创造新的针对患者的3D打印鞋垫 使用个性化的超材料，我们相信这将显示出卓越的卸载性能。 个性化超材料是由来自患者的晶格图案形成的3D打印材料- 特定的特性，导致鞋垫与患者的需求唯一匹配。的目的是 这项研究旨在确定采用个性化超材料的3D打印鞋垫是否可以降低足底压力 对于脚部高危部位的护理鞋垫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鞋垫将根据足底形状和动态足底压力进行设计 而3DP-FE鞋垫将通过模拟参与者的脚与不同的 鞋垫设计优化鞋垫形状和超材料性能。在一项重复测量研究中， 我们将测量每种类型鞋垫的最大足底压力和压力时间积分 25名患有糖尿病和前脚压力升高的参与者。我们假设3D打印机 由来自足底测量(3DP-PB)的个性化超材料组成的鞋垫将具有 与SC鞋垫相比，足底峰值压力和压力时间积分的降低幅度更大(H1)。 此外，我们假设，相对于其他两种鞋垫，鞋垫是通过患者- 特定的有限元模拟(3DP-FE)将最大限度地降低足底峰值压力和 压力时间积分(H2)。为了方便新型3D打印鞋垫的临床翻译，我们将 与患者和临床医生组成焦点小组，以获得他们的早期反馈和见解。来自这些的结果 焦点小组将被定性地合成为可操作的鞋垫改进。新颖的鞋垫 利用3D打印制造可以提供增强的保护，防止频繁的足部溃疡 截肢的进展。此外，数字化制造技术和3D制造方法已经 大规模生产的门槛相对较低，这可以大大加快转化为临床的速度。退伍军人事务部 被公认为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，这与退伍军人管理局的创新精神非常一致，并得到了 弗吉尼亚的使命是“照顾将要承担这场战斗的人”。降低退伍军人的溃烂率 人口有可能极大地减少下肢截肢的发生率并提高质量 我们退伍军人的生活。

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.