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Transdermal H2S Sensing Device for Monitoring Peripheral Artery Disease

用于监测外周动脉疾病的透皮 H2S 传感装置

基本信息

批准号：
9764459
负责人：
Nancy L Kanagy
金额：
$ 70.9万
依托单位：
EXHALIX, LLC
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-06 至 2021-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9764459
关键词：
Address Adoption Advanced Development Affect Age American Animals Arteries Atherosclerosis Biological Assay Biological Markers Blood Vessels Blood flow Blood specimen Cardiovascular Physiology Cell Line Center for Translational Science Activities Cerebrovascular Disorders Characteristics Clinical Clinical Research Clinical Sciences Collaborations Coronary Arteriosclerosis Data Data Analyses Detection Development Devices Diabetes Mellitus Diabetic Angiopathies Diabetic Nephropathy Diabetic Retinopathy Diagnosis Diagnostic Diagnostic Equipment Disease Distal Early Diagnosis Early treatment Economics Eligibility Determination Endothelial Cells Endothelium Engineering Environment Equipment Evaluation Feasibility Studies Female Gases Geometry Government Health Care Costs Hospitalization Human Hydrogen Sulfide Insulin-Dependent Diabetes Mellitus Insurance Intervention Investigation Ischemia Kidney Diseases Laboratories Laser Speckle Imaging Limb structure Lower Extremity Measurement Measures Medical Methods Microvascular Dysfunction Modeling Monitor Morbidity - disease rate Muscle Myocardial Infarction Neuropathy New Mexico Nurses Organ Pain Pancreas Pathologic Patient Care Patient-Focused Outcomes Patients Performance Perfusion Peripheral Nervous System Diseases Peripheral arterial disease Phase Physicians Physiological Plasma Prediabetes syndrome Protocols documentation Provider Quality of life Rattus Reading Recovery Reproducibility Research Research Personnel Resources Risk Factors Role Sampling Scientist Secure Site Skin Small Business Innovation Research Grant Small Business Technology Transfer Research Sprague-Dawley Rats Streptozocin Techniques Technology Testing Time Toxic effect Universities Upper Extremity Validation Vascular Diseases Vascular Endothelium Vascular calcification Vasodilator Agents care costs care providers commercialization coronary vascular disease cost detector diabetic diabetic patient diabetic rat effective therapy endothelial dysfunction equipment training experience high risk high risk population human subject improved in vivo ineffective therapies innovation instrument instrumentation male medical schools monitoring device mortality myocardial damage patient population phase 2 study point of care portability prevent prototype research study routine screening seal sensor sex temporal measurement user-friendly vascular endothelial dysfunction

项目摘要

Project Summary/Abstract Peripheral artery disease (PAD) and small vessel disease (SVD) are the consequences of damage to the endothelial cells that line all vessels, both leading to inadequate skin perfusion and end-organ and limb damage. It is prevalent in diabetic patient population in which nearly 50% suffers from PAD and SVD. The proposed effort addresses an unmet need for early diagnosis of PAD and SVD in this high-risk group. A number of studies describe the difficulties in diagnosing arterial disease in diabetic patients, including the high risk of vascular calcification, which leads to overestimates of limb blood flow by ABI measurements and missed diagnosis of partial occlusions. Despite the important role of skin perfusion, it is seldom detected or even tested for in its early stages due to the lack of routine screening protocols and the requirement for expensive diagnostic equipment and trained technicians. This highlights the significant opportunity for development of a simple, inexpensive protocol to routinely screen subjects with skin perfusion risk factors early enough that would allow more effective treatment options for diabetic retinopathy, neuropathy, limb ischemia, cerebral vascular disease, coronary vascular disease and nephropathy. Creating a way to detect vascular disease at a point where changes are reversible will: 1) improve patient quality of life by delaying or preventing the development of end organ damage; and 2) decrease patient care costs. The proposed protocol utilizes hydrogen sulfide (H2S), a newly described endothelium-derived vasodilator that decreases with the onset of endothelial disease, the underlying cause of most PAD and SVD cases. Furthermore, normal levels of H2S are beneficial for preventing endothelial dysfunction, for improving recovery from muscle ischemia and in mitigating damage from myocardial infarction. There is currently no non-invasive method to accurately measure plasma H2S and the few existing techniques require specialized equipment and skilled technicians. Our proposed technology, the transdermal gasotransmitter sensor (TAGS™), employs an innovative gas-phase detector which noninvasively measures plasma levels of H2S. In the STTR Phase I feasibility study, the Exhalix and University of New Mexico team developed and used a laboratory version of TAGS to perform preliminary animal studies in which physiologically relevant normal and reduced plasma levels of H2S were transdermally detected in male Sprague-Dawley rats. During the proposed SBIR Phase II renewal studies, we intend to continue the development of advanced prototypes of TAGS. These prototypes will be verified and validated across a broad cross-section of subjects, including healthy and diabetic animal and human subjects of both sexes, in collaboration with experienced physician scientists at the School of Medicine and the Center for Translational and Clinical Sciences. We anticipate that successful development and validation of TAGS during Phase II will lead to Phase IIB clinical studies and commercialization of the technology.

项目总结/文摘

项目成果

期刊论文数量（1）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（1）

Validation of the novel transdermal arterial gasotransmitter sensor (TAGS™) system in measuring transdermal hydrogen sulfide in human subjects.

验证新型透皮动脉气体递质传感器 (TAGS™) 系统在人体中测量透皮硫化氢的效果。

DOI：
10.1016/j.sbsr.2022.100523
发表时间：
2022
期刊：
Sensing and Bio-Sensing Research
影响因子：
5.3
作者：
Matheson,BT;Osofsky,RB;Friedrichsen,DM;Brooks,BJ;Clark,RM;Kanagy,NL;Shekarriz,R
通讯作者：
Shekarriz,R