Modulated Imaging in Comprehensive Assessment of Diabetic Foot Ulcer Development

描述(申请人提供)：2010年，糖尿病影响了全球2.85亿成年人，预计到2030年，糖尿病患病率将增加到4.39亿人。足部溃疡仍然是糖尿病的主要并存疾病，在1型和2型患者中，有15%到25%的患者在一生中会受到影响。事实上，在糖尿病患者的所有截肢手术中，大约85%的患者在接受截肢手术之前都会出现足部溃疡。未经治疗的糖尿病足溃疡和随后的截肢对糖尿病患者的生活质量有深远的影响。最后，2007年，美国对糖尿病及其并发症的治疗产生了至少1160亿美元的直接成本；其中至少33%的成本与足部溃疡的治疗有关。组织灌注、血氧饱和度和水合作用已被证明可以预测溃疡愈合和形成。这些数量提供了对皮肤新陈代谢、微观结构和健康状况的洞察。漫反射光谱(DOS)是一种很有前途的在体局部组织灌流、氧合、水化和微结构测量技术。DOS是一种定量近红外(NIR)光谱技术，可以测定生色团的绝对浓度，如氧合和脱氧血红蛋白、脂肪和水。调制成像(MI)是BLI发明的一种基于DOS原理的近红外成像方法，它使用图案化照明来询问生物组织。这种非接触式的方法可以在大视场范围内快速定量测定发色团的光学性质和体内浓度。更重要的是，MI还可以用来测量组织减少的散射系数，从而深入了解溃疡形成和愈合过程中由于胶原疤痕、骨痂形成、坏死或炎症而导致的组织微观结构变化。这项拟议研究的中心目标是证明调制成像(MI)是预测/监测糖尿病足并发症的一种手段。我们建议开发两层计算技术，以提高从具有强烈黑色素沉着或厚骨痂的足部皮肤获得的数据的准确性和精确度。一旦这个MI系统、算法和软件在组织模拟模型上得到验证，我们将收集表现为糖尿病足溃疡的受试者的数据。使用这些数据将开发出溃疡形成和愈合的预测模型。这项初步研究的结果将被用于仔细设计第二阶段研究，以建立基于MI的模型预测溃疡形成和愈合的预测能力。 公共卫生相关性：足部溃疡仍然是糖尿病的主要共同发病率，在1型和2型患者的一生中，有多达15%到25%的患者受到影响。我们建议使用新的成像技术(调制成像)来促进溃疡形成或无法愈合的预测。我们的技术有可能显著降低糖尿病足部溃疡的人力和经济成本。

DESCRIPTION (provided by applicant): Diabetes mellitus affected 285 million adults worldwide in 2010 and is expected to increase in prevalence to 439 million people by the year 2030. Foot ulceration continues to be a major comorbidity of diabetes and afflicts as many as 15 to 25% of subjects with type 1 and 2 during their lifetime. In fact, roughly 85% of all lower extremity amputations in patients with diabetes mellitus are preceded by a foot ulcer. Untreated diabetic foot ulceration and subsequent amputation has a profound impact on the quality of life of the diabetic patient. Finally, in 2007, the treatment of diabetes and its complications in the United States generated at least $116 billion in direct costs; at least 33% of these costs were linked to the treatment of foot ulcers. Tissue perfusion, oximetry, and hydration have been shown to predict ulcer healing and formation. These quantities provide insight into the metabolism, microstructure and health of the skin. One promising technology for measuring local tissue perfusion, oxygenation, hydration, and microstructure in-vivo is diffuse optical spectroscopy (DOS). DOS is a quantitative near-infrared (NIR) spectroscopy technique that can determine absolute concentrations of chromophores such as oxy & deoxy hemoglobin, fat and water. Modulated Imaging (MI) is a NIR imaging method invented at BLI that is based on the principles of DOS and employs patterned illumination to interrogate biological tissues. This non-contact approach enables rapid quantitative determination of the optical properties and in-vivo concentrations of chromophores over a wide field-of-view. More importantly, MI can also be used to measure the tissue's reduced scattering coefficient and thus gain insight into microstructural changes in the tissue during ulcer formation and healing due to collage scarring, callus formation, necrosis, or inflammation. The central aim of the proposed research is to prove Modulated Imaging (MI) as a means to predict/monitor complications of the diabetic foot. We propose to develop two-layer computational techniques that will enhance the accuracy and precision of data obtained from foot skin having strong melanin pigmentation or thick callus. Once this MI system, algorithm, and software have been validated on tissue simulating phantoms, we will collect data from subjects exhibiting diabetic foot ulceration. A predictive model for ulcer formation and healing will be developed using this data. Results from this pilot study will be used to carefully design a Phase II study to establish the predictive power of MI-based models to predict ulcer formation and healing. PUBLIC HEALTH RELEVANCE: Foot ulceration continues to be a major co-morbidity of diabetes and afflicts as many as 15 to 25% of subjects with type 1 and type 2 during their lifetime. We propose to use novel imaging technology (Modulated Imaging) to facilitate prediction of ulcer formation or non-healing. Our technology has the potential to significantly reduce the human and financial cost of diabetic foot ulceration.