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

调制成像在糖尿病足溃疡发展和愈合综合评估中的应用

基本信息

批准号：
9324204
负责人：
David John Cuccia
金额：
$ 80.94万
依托单位：
MODULATED IMAGING, INC.
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-04-01 至 2019-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9324204
关键词：
Academia Acute Adult Affect Algorithms Arizona Biological Biometry Blood Vessels Bone callus Caring Clinical Clinical Data Clinical Research Comorbidity Computer Simulation Computer software County Coupled Data Development Devices Diabetes Mellitus Diabetic Foot Diabetic Foot Ulcer Disease Disease remission Dorsal Edema Foot Ulcer Funding Future Goals Health Hemoglobin Image Imaging Device Imaging technology Impaired wound healing Industry Insulin-Dependent Diabetes Mellitus Intervention Isolated limb perfusion Light Lighting Limb Salvage Lower Extremity Measures Medical Medical Imaging Modeling Monitor Morphologic artifacts Motion Non-Insulin-Dependent Diabetes Mellitus Optics Oranges Outcome Patients Pattern Phase Pilot Projects Prevalence Prevention Property Recording of previous events Research Research Design Risk Side Skin Small Business Innovation Research Grant Spatial Frequency Domain Imaging Staging System Technology Testing Time Tissues Translations Treatment outcome Ulcer Water Work absorption base chromophore clinical application clinical care commercialization cost design expectation foot healing improved in vivo indexing insight instrumentation limb amputation mortality new technology prediction algorithm prevent programs screening spectrograph systems research tissue oxygenation tool treatment response user-friendly wound wound closure

项目摘要

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.

抽象的糖尿病在2013年全球影响了3.82亿成年人，预计将增加到2035年，到5.92亿人口的患病率。足球溃疡仍然是主要的糖尿病和折磨的合并症多达25％的1型糖尿病患者在他们的一生中。由于DFU管理差而导致的下肢截肢是全球负担这与77％的5年死亡率有关，累计使该系统付出了代价每位患者约70,000美元。有效的预防和治疗足溃疡可以是由于缺乏客观标准而受到阻碍，无法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，这是一个新的临床上可行的工具，可对疾病阶段，进展和治疗反应，成为用于筛查和管理糖尿病脚的临床可行的工具溃疡。 MI是一种非接触成像技术，它决定了体内浓度的浓度与组织健康相关的地下发色团（即血红蛋白，氧合，水肿和散射）。该建议的目的是开发一个用户友好的专用MI平台系统用于研究MI衍生的生物特征（例如血红蛋白，氧合和散射）的价值糖尿病脚。在此II阶段计划中，我们将构建一个DFU-MI设备并执行三个飞行员研究评估我们技术影响糖尿病足护理能力的研究。首先，我们会的表征对照和脚部的血管反应性，以确定溃疡的“有风险” 正常的MI生物特征。其次，我们将研究我们预测英尺新逻辑形成的能力在“缓解”中考虑的，但重新拆除的可能性> 35％。最后，我们将学习血管干预后的下肢灌注变化和现有伤口以评估在伤口闭合之前的功效。我们的II期研究将确定MI的插入点进入DFU临床护理的技术，并洞悉未来的III期临床研究假设和设计以构建具有特定指示的医学成像设备伤口预测和康复。