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: 10609500
• 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 2026-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10609500
• 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; Property; Quality of life; Reporting; Research Personnel; Risk; Risk Reduction; Shapes; Shoes; Speed; Structure; 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; fabrication; foot; high risk; imprint; improved; improved outcome; innovation; insight; large scale production; limb amputation; limb loss; manufacture; manufacturing process; manufacturing technology; 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，全球每30秒就有一例下肢截肢，其中85%的患者