Patient Specific 3D Printed Diabetic Insoles to Reduce Plantar Pressure

患者专用 3D 打印糖尿病鞋垫可减少足底压力

• 批准号: 10425710
• 负责人: Brittney C Muir
• 金额: --
• 依托单位: VA PUGET SOUND HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10425710
• 关键词: 3-Dimensional; 3D Print; Amputation; Area; Behavior; Caring; Characteristics; Clinic; Clinical; Computer software; Custom; Development; Devices; Diabetes Mellitus; Diabetic Foot Ulcer; Effectiveness; Elements; Feedback; Financial Hardship; Finite Element Analysis; Foam Cells; Focus Groups; Foot Ulcer; Geometry; Grant; Hand; Head; Healthcare; Healthcare Systems; Incidence; Individual; Judgment; Life; Lower Extremity; Measurement; Measures; Mechanical Stress; Medicine; Metatarsal bone structure; Methods; Mission; Morbidity - disease rate; Non-Insulin-Dependent Diabetes Mellitus; Participant; Patients; Pattern; Performance; Peripheral Nervous System Diseases; Plantar Ulcers; Prevention; Production; Property; Quality of life; Reporting; Research Personnel; Risk; Shapes; Shoes; Speed; Surface; Survival Rate; Techniques; Technology; Testing; Therapeutic; Time; Tissues; Translations; Ulcer; Veterans; Walking; Weight-Bearing state; base; clinical practice; clinical translation; cost; design; diabetic; digital; experience; foot; high risk; imprint; improved; improved outcome; innovation; insight; limb amputation; limb loss; manufacturing process; medical specialties; military veteran; novel; pressure; programs; recruit; simulation; soft tissue; standard of care; ultrasound

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.

据估计，在全球范围内，下肢截肢每30秒进行一次，而85％ 这些截肢是糖尿病足溃疡的结果。足底足溃疡，部分原因是 脚的柔软的尖端加载和机械应力。定制的护理鞋垫旨在减少 通过将压力重新分布到其他地区，脚部的脚部地区遭受了过多的足底压力。 但是 高度高。同时，3D打印技术，材料属性和数字革命的革命 制造管道正在实现一波创新的解决方案，这些解决方案正在改善许多结果 医学领域。我们旨在利用这些技术来创建新颖的患者特异性3D印刷鞋垫 我们认为，具有个性化的超材料将表现出卓越的卸载性能。 个性化的超材料是由晶格图案形成的3D印刷材料 特定特征，导致鞋垫与患者的需求唯一匹配。目的 这项研究是为了确定带有个性化超材料的3D打印鞋垫是否减少了足底压力 对于脚的高风险区域比护理标准鞋垫更好。我们将制造三种不同的鞋垫， 即护理标准（SC），基于3D打印压力（3DP-PB）和有限元的优化 （3DP-FE）鞋垫。 3DP-PB鞋垫将以底脚形状和动态足底压力设计 虽然3DP-FE鞋垫将是根据参与者脚相互作用的模拟而设计的 鞋垫设计以优化鞋垫形状和超材料特性。在一项重复的措施研究中 我们将测量每种类型的鞋垫的峰值足底压力和压力时间积分 有25名患有糖尿病和较高较高压力的参与者。我们假设3D打印了 从足底测量值（3DP-PB）得出的个性化的超材料完成的鞋垫将 与SC鞋垫（H1）相比，峰值峰值压力和压力时间积分的降低更大。 此外，我们假设相对于其他两个鞋垫，通过患者优化了鞋垫 特定的有限元模拟（3DP-FE）将在峰值峰值压力和 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 与患者和临床医生分散焦点小组，以获得早期的反馈和见解。这些结果 焦点小组将被定性地合成为鞋垫的可行改进。新型鞋垫 利用3D打印制造可能会提供增强的防护，以免经常 进展到截肢。此外，数字制造技术和3D制造方法具有 与大规模生产的相关障碍相关，这可以大大加快转化为诊所。 VA是 被公认为是医疗保健创新的领导者。自定义3D打印鞋垫的开发 这可能会降低截肢的风险，与VA的创新精神相吻合，并得到 弗吉尼亚州的任务“照顾那些要诞生的战斗的人。”降低退伍军人的溃疡发生率 人口有可能大大降低下限截肢的发生率并提高质量 我们的退伍军人生活。