Smartphone-based optical scanner to physiologically assess diabetic foot ulcers

项目总结 每三名糖尿病患者中就有一人有患糖尿病足溃疡(DFU)的风险，超过10%的人被截肢。 当前的全球大流行推动了医疗保健服务的重大变化，并扰乱了DFU的护理和 肢体保护，使许多患者的临床护理有限或根本没有。 临床医生必须采取范式转变 从医院和诊所护理到基于社区的护理点(POC)-再到对慢性DFU病例进行最佳分诊 是需要临床护理或住院的高危病变。对智能健康的临床需求尚未得到满足 现场没有伤口护理专业知识的DFU患者的POC治疗评估工具。 用于伤口护理的智能手机技术仅限于对伤口大小/深度的2D/3D伤口图像分析。他们是 在没有现场创伤专业知识的情况下，不足以作为独立的工具来评估和分类高危DFU损伤。 因此，在POC期间需要进行额外的临床评估(例如，伤口供氧的程度) 现场DFU。 氧合测量提供了亚临床生理评估，补充了 临床视觉评估。我们最近开发了一种基于智能手机的近红外成像方法，即智能手机 氧合工具(SPOT)，用于测量伤口中的可视组织氧合。系统化 在生理成像过程中，皮肤色调和伤口特征的评估是至关重要的，目前还没有 到目前为止已经调查过了。因此，我们的目标是开发和验证基于智能手机的成像方法 (或智能扫描仪)能够对各种肤色和光谱的DFU进行视觉和生理分析 通过自动机器学习(ML)算法创建特征。开发基于智能手机的光学设备 通过整合现有的近红外成像技术，向智能生理健康平台迈进 DFU的评估，同时使用ML算法考虑不同的肤色和伤口类型是 创新。具体目标是：(I)通过以下方式说明肤色对氧合测量的影响 应用光传播模型和机器学习算法，并通过模型和体内研究进行验证。 (Ii)通过对照研究，分析组织曲率并解释体内氧合图的深度变化 受试者(约15例)。(Iii)区分伤口组织类型，并利用斑点验证生理成像 经DFU检查(约25例)。预期的结果是：(I)开发我们的智能扫描仪(Spot 设备+APP)，以获得不同肤色和伤口组织类型的准确组织氧合地图； (Ii)验证我们的SPOT设备，以区分具有需要临床护理的高风险病变的DFU与低风险病变 案子。DFU的发病率和相关截肢率因种族/民族而异，在非洲较高 美国人、西班牙人和美洲原住民与高加索人相比。从长远来看，Spot可以用作 一种智能健康工具，可对具有高风险病变的DFU进行预先筛查或分类，以供临床护理，从而最大限度地减少潜在风险 任何种族/民族(肤色不同)的截肢。

PROJECT SUMMARY One in three people with diabetes mellitus is at risk of diabetic foot ulcers (DFUs), with over 10% amputated. The current global pandemic has driven a significant change in healthcare delivery and disrupted DFU care and limb preservation, leaving many patients with limited or no clinical care. Clinicians must adopt a paradigm shift from the hospital and clinic care to community-based point-of-care (POC) - to best triage chronic DFU cases that are high-risk lesions requiring clinical care or hospitalization. There is an unmet clinical need for smart health assessment tools for POC treatment of patients with DFUs onsite, where no wound care expertise is available. Smartphone technologies for wound care are limited to 2D/3D wound image analysis for size/depth. They are insufficient as stand-alone tools to assess and triage high-risk DFU lesions without wound expertise onsite. Hence, additional clinical assessments (e.g., the extent of oxygen supply to wound) are required during POC of DFUs onsite. Oxygenation measurements provide a sub-clinical physiological assessment that complements clinical visual assessment. We recently developed a smartphone-based NIR imaging approach or SmartPhone Oxygenation Tool (SPOT) to obtain visual tissue oxygenation measurements in wounds. Systematic assessment of the skin tone and wound characteristics is critical during physiological imaging and has not been investigated to date. Hence, our objective is to develop and validate a smartphone-based imaging approach (or Smart Scanner) capable of visual and physiological analysis of DFUs across the spectrum of skin tones and wound features via automated machine learning (ML) algorithms. Developing a smartphone-based optical device via integration of existing NIR imaging technology, but towards smart health platform for physiological assessment of DFUs, while accounting for varying skin colors and wound types using ML algorithms is innovative. The specific aims are: (i) Account for the effect of skin tones on oxygenation measurements by applying light propagation models and machine learning algorithms and validate via phantom and in-vivo studies. (ii) Analyze tissue curvatures and account for depth variations in-vivo oxygenation maps via studies on control subjects (~15 cases). (iii) Differentiate wound tissue types and validate physiological imaging using the SPOT device via DFU studies (~25 cases). The expected outcomes are: (i) Develop our Smart Scanner (SPOT device + app) to obtain accurate tissue oxygenation maps across different skin tones and wound tissue types; (ii) Validate our SPOT device to differentiate DFUs with high-risk lesions that require clinical care, from low-risk cases. Incidence of DFUs and related amputation rates differ by race/ethnicity, and are higher in African Americans, Hispanic and Native Americans compared to Caucasians. In the long term, SPOT can be used as a smart health tool to pre-screen or triage DFUs with high-risk lesions to clinical care and thus minimize potential amputations in any racial/ethnic group (with varying skin tones).