Modulated Imaging in Comprehensive Assessment of Diabetic Foot Ulcer Development and Healing

摘要 2013年，糖尿病影响了全球3.82亿成年人，预计2014年将增加。 到2035年将达到5.92亿人。足部溃疡仍然是一个主要的 糖尿病合并症，并且折磨多达25%的1型和2型糖尿病受试者 在他们的一生中。由于DFU管理不善导致的下肢截肢是全球负担 这与77%的5年死亡率相关，并累积花费系统 每名患者约7万元。有效的预防和治疗足部溃疡可以 由于缺乏客观标准来定量跟踪足部健康和评估 治疗结果。这项研究的广泛目标是开发调制成像，一种新的 临床上可行的工具，可提供对疾病阶段、进展和 治疗反应，成为临床上可行的工具，用于筛查和管理糖尿病足 溃疡MI是一种非接触式成像技术，可测定体内的 与组织健康相关的表面下发色团（即血红蛋白、氧合、水肿和 散射）。本提案的目标是开发一个用户友好的专用管理信息平台系统 用于研究MI衍生的生物特征（如血红蛋白、氧合和散射）在 糖尿病足在这个第二阶段计划中，我们将建立一个DFU-MI设备，并进行三个试点， 研究评估我们的技术对糖尿病足护理的影响。一是 表征对照组和被认为“有溃疡风险”的足部的血管反应性，以确定 标准MI生物特征。第二，我们将研究我们预测足部新伤口形成的能力 被认为是“缓解”，但有>35%的机会再溃疡。最后，我们将研究 血管介入治疗后下肢血流灌注变化与现有伤口评估 在伤口闭合之前的功效。我们的第二阶段研究将确定MI的插入点 技术融入DFU临床护理并为未来的III期临床研究提供见解 为了构建具有特定适应症的医学成像设备， 伤口预测和愈合。

ABSTRACT Diabetes mellitus affected 382 million adults worldwide in 2013 and is expected to increase in prevalence to 592 million people by the year 2035. Foot ulceration continues to be a major comorbidity of diabetes and afflicts as many as 25% of subjects with type 1 and 2 diabetes during their lifetime. Lower limb amputations due to poor DFU management are a global burden that is associated with a 77% 5-year mortality rate and cumulatively costs the system approximately $70,000 per patient. Effective prevention and treatment of foot ulcers can be hindered due to a lack of objective standards to quantitatively track foot health and assess treatment outcomes. The broad goal of this research is to develop Modulated Imaging, a new clinically-viable tool which provides quantitative insight into disease stage, progression and therapeutic response, into a clinically-viable tool for screening and managing diabetic foot ulcers. MI is a non-contact imaging technology that determines the in-vivo concentrations of subsurface chromophores relevant to tissue health (i.e. hemoglobin, oxygenation, edema and scattering). The goal of this proposal is to develop a user-friendly dedicated MI platform system for studying the value of MI-derived biometrics (like hemoglobin, oxygenation, and scattering) in the diabetic foot. In this Phase II program, we will build a DFU-MI device and perform three pilot studies to assess the capability of our technology to impact diabetic foot care. First, we will characterize vascular reactivity in control and feet considered “at risk” for ulcer to determine normative MI biometrics. Second, we will study our ability to predict new wound formation in feet that are considered in “remission” but with a >35% chance of re-ulceration. Finally, we will study lower limb perfusion changes after vascular intervention for and existing wound to assess efficacy prior to wound closure. Our Phase II research will determine the insertion point of MI technology into DFU clinical care and provide insight to future Phase III clinical study hypotheses and designs in order to build a medical imaging device with indications specific to wound prediction and healing.