Near InfraRed Layered Imaging of Tissue Hemodynamics (NIR-LITH)

组织血流动力学近红外分层成像 (NIR-LITH)

• 批准号: 10758694
• 负责人: LAWRENCE A LAVERY
• 金额: $ 33.15万
• 依托单位: VIVONICS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-11 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10758694
• 关键词: 3-Dimensional; Algorithms; Amputation; Ankle; Biological Markers; Biopsy; Blood Vessels; Calibration; Caring; Circulation; Classification; Clinical assessments; Collaborations; Color; Complement; Complex; Confidence Intervals; Data; Debridement; Deterioration; Diabetic Foot Ulcer; Diagnosis; Discrimination; Dyes; Economic Burden; Edema; Evaluation; Eye; Generations; Goals; Hospitalization; Human; Image; Imaging Techniques; In Vitro; Individual; Infection; Injections; Intervention; Knowledge; Length; Light; Manuals; Maps; Measurement; Measures; Medical Staff; Medical center; Medicare; Methods; Morbidity - disease rate; Neuropathy; Operative Surgical Procedures; Optics; Outcome; Oxygen; Patient-Focused Outcomes; Patients; Penetration; Performance; Perfusion; Phase; Physical Examination; Physiologic pulse; Physiological; Procedures; Process; Property; Pus; ROC Curve; Redness; Resolution; Risk Factors; Sampling; Sensitivity and Specificity; Skin; Small Business Innovation Research Grant; Source; Surface; Surgeon; Surgical wound; Swelling; System; Techniques; Technology; Testing; Texas; Time; Tissue Viability; Tissue imaging; Tissues; Toes; Trauma; Ulcer; Universities; Vascular Diseases; Visual; Work; algorithm development; chronic wound; clinical examination; clinical practice; cost; data acquisition; design; diabetes management; diabetic patient; experience; healing; hemodynamics; high risk; human tissue; image reconstruction; imaging approach; imaging capabilities; imaging system; improved; indexing; innovation; interest; mortality; non-invasive imaging; operation; polarized light; portability; pressure; programs; prototype; reconstruction; recruit; skills; socioeconomics; spectrograph; statistics; tool; wound; wound care; wound healing; wound treatment

Project Summary/Abstract Diabetic foot ulcers (DFU) are associated with significant morbidity and mortality, with a 2.5x higher risk of 5-year mortality compared to diabetic patients without DFUs [3, 4]. The reason behind these dramatic statistics is tied to the lack of objective metrics for monitoring wound progress or deteriorating conditions. Assessment of functional perfusion is one of the biggest unmet needs for predicting wound healing. Current clinical practices still rely heavily on visual observation and clinical examination of the wound, an approach in which successful prediction of healing or amputation level survival is poor even among very experienced clinicians. The proposed innovative solution will complement the current standards of care for the characterization of DFUs by providing objective metrics and will provide details that can be missed during routine visual inspections and clinical assessments only. This solution will allow the clinician to select an appropriate management strategy for the specific case by providing clear images relative to potentially compromised circulation. The aim of the herein proposed work is to provide a three-dimensional hemodynamic map of the imaged DFU and surrounding tissue, with a controllable ≈1 mm depth resolution over a depth from 0 to 0.5 cm to assess different degrees of microcirculatory perfusion and hemodynamics. This approach will provide objective and immediate assessment of DFU and surgical wound healing potential and will help clinicians make more accurate and faster treatment decisions. In complex cases, it will help surgeons select a level amputation that will still be able to heal, reducing the number of surgeries and the length of hospitalizations. We call this system NIR-LITH (Near InfraRed Layered Imaging of Tissue Hemodynamics). The system herein proposed leverages a non-contact optical- based system for tissue viability assessment, previously developed at Vivonics, to provide objective metrics about tissue viability to surgeons during debridement procedures. In order to achieve this overarching goal, the following specific aims have been proposed:  Aim 1: Enhance first generation prototype to improve depth discrimination capabilities. Controllable depth imaging capabilities (0-0.5cm) for tissue layers discrimination (≈1 mm) is the goal of this task.  Aim 2: Develop algorithm for depth discrimination and phantom testing and characterization.  Aim 3: System evaluation: thirty DFU patients in collaboration with Dr. L. Lavery at the University of Texas Southwestern Medical Center (UTSW) will be recruited for this task and gold standard analysis will comparted against the NIR-LITH results.

项目概要/摘要 糖尿病足溃疡 (DFU) 与显着的发病率和死亡率相关，其风险增加 2.5 倍 与没有 DFU 的糖尿病患者相比，5 年死亡率[3, 4]。这些引人注目的统计数据背后的原因 与缺乏监测伤口进展或病情恶化的客观指标有关。评估 功能灌注是预测伤口愈合最大的未满足需求之一。目前的临床实践 仍然严重依赖对伤口的目视观察和临床检查，这种方法成功 即使是经验丰富的临床医生，对治愈或截肢水平生存的预测也很差。拟议的 创新的解决方案将补充当前 DFU 表征的护理标准，通过提供 客观指标，并将提供在常规目视检查和临床过程中可能遗漏的细节 仅评估。该解决方案将允许临床医生为该疾病选择适当的管理策略 通过提供与潜在的循环受到损害相关的清晰图像来具体情况。本文的目的 提出的工作是提供成像 DFU 和周围组织的三维血流动力学图， 在 0 至 0.5 cm 的深度上具有可控的 ≈1 mm 深度分辨率，以评估不同程度的 微循环灌注和血流动力学。这种方法将提供客观和即时的评估 DFU 和手术伤口愈合潜力，将帮助临床医生做出更准确、更快速的治疗 决定。在复杂的情况下，它将帮助外科医生选择仍然能够愈合的水平截肢，减少 手术次数和住院时间。我们将此系统称为 NIR-LITH（近红外 组织血流动力学分层成像）。本文提出的系统利用非接触式光学 之前由 Vivonics 开发的基于组织活力评估的系统，以提供客观指标 关于外科医生在清创手术期间组织活力的信息。为了实现这一总体目标， 提出了以下具体目标：  目标 1：增强第一代原型以提高深度辨别能力。可控 本任务的目标是区分组织层（约 1 毫米）的深度成像能力（0-0.5 厘米）。 目标 2：开发深度辨别以及体模测试和表征的算法。 目标 3：系统评估：30 名 DFU 患者与纽约大学 L. Lavery 博士合作 将招募德克萨斯西南医学中心 (UTSW) 来执行这项任务和黄金标准分析 将与 NIR-LITH 结果进行比较。