SKIN BIOPSY AND BLISTER--NEW METHODS TO STUDY NEUROPATHY

这个提议的目标是：1)制造和销售一种皮肤 活组织检查试剂盒，使医生、诊所和医院人员能够 很容易从患者那里获得皮肤活检和皮肤水泡样本 运往参考实验室进行诊断解释， 或用于比较在治疗性临床治疗之前和期间采集的样本 实验，2)研究皮神经的特性，以获得一个 对正常人和疾病患者皮神经形态的认识 各州。为实现这一目标，我们将实现以下具体目标 第二个目标：a)检查正常人和老年人的皮神经 最小的神经病变，主要是糖尿病神经病变，以确定 皮肤活检和水疱法的敏感性，b)研究 神经病患者术后皮神经再生能力的研究 化学和物理远端去神经，c)建立一个数据库 皮肤活检和水泡分析的皮神经正常值 取自正常人的样本。 建议的商业应用： 在美国大约有1300万糖尿病患者， 他们中的大多数都有神经病。早期诊断很重要 开始强化治疗以阻止神经病的进展。 治疗糖尿病的几项临床试验正在进行中 未经证实的确定患者受益标准的神经病。在……里面 此外，工人赔偿案件的数量不断增加 这需要客观地评估神经损伤的程度。这些 需求为活检试剂盒创造了一个商业市场，该试剂盒将提供 一种客观、分析的方法来评估皮肤神经病变 社区医生。诊所和医院。

The objectives of this proposal are: 1) to manufacture and market a skin biopsy kit that will enable physicians, clinic and hospital personnel to easily obtain skin biopsy and skin blister specimens from patients for shipment to a reference laboratory for either diagnostic interpretation, or for comparing samples acquired before and during a therapeutic clinical trial, and 2) to research the properties of cutaneous nerves to acquire an understanding of the morphology of cutaneous nerves in normal and disease states. The following specific aims will be pursued to accomplish the second objective: a) examine cutaneous nerves of normal persons and those with minimal neuropathy, mainly diabetic neuropathy, to determine the sensitivity of the skin biopsy and blister methods, b) study the regenerative capacity of cutaneous nerves of persons with neuropathy after chemical and physical distal denervation, c) to create a data base of normal values for cutaneous nerves by analysis of skin biopsy and blister samples from normal human subjects. PROPOSED COMMERCIAL APPLICATION: There arc approximately 13 million diabetic patients in the USA, the majority of whom have neuropathy. Early diagnosis is important for initiation of intensive treatment to stop progression of neuropathy. Several clinical trials are in progress for treatment of diabetic neuropathy without proven criteria for determining patient benefit. In addition, there are increasing numbers of workman's compensation cases that require objective evaluation of the extent of nerve injury. These needs create a commercial market for a biopsy kit that will make available an objective, analytical method to evaluate cutaneous nerve disorders to community physicians. clinics and hospitals.