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#年将有所增加 到2035年，患病率将达到5.92亿人。足部溃疡仍然是一个主要问题。 高达25%的1型和2型糖尿病患者合并糖尿病和糖尿病 在他们有生之年。由于DFU管理不善而导致的下肢截肢是全球的负担 这与77%的5年死亡率相关，并累积花费该系统 每个病人大约70,000美元。可以有效地预防和治疗足部溃疡 由于缺乏量化跟踪足部健康和评估的客观标准而受阻 治疗结果。这项研究的总体目标是开发调制成像，一种新的 临床上可行的工具，提供对疾病阶段、进展和 治疗反应，成为临床上可行的糖尿病足筛查和治疗工具 溃疡。MI是一种非接触式成像技术，可以确定体内的浓度 与组织健康有关的表面下发色团(即血红蛋白、氧合作用、水肿和 散射)。该方案的目标是开发一个用户友好的专用MI平台系统 为了研究心肌梗死衍生的生物特征(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，我们将建造一个DFU-MI设备，并执行三个试点 评估我们的技术影响糖尿病足部护理的能力的研究。首先，我们将 确定对照和足部被认为有溃疡风险的血管反应性的特征 标准MI生物识别。其次，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”的，但有35%的机会再次溃疡。最后，我们将研究 血管介入治疗后肢体血流灌注变化及对现存伤口的评估 伤口闭合前的疗效。我们的第二阶段研究将确定MI的插入点 技术应用于DFU临床护理，并为未来的III期临床研究提供洞察力 假设和设计，以建立一种具有特定于 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.