SKIN BIOPSY AND BLISTER--NEW METHODS TO STUDY NEUROPATHY

该提案的目标是：1）制造和销售皮肤 活检套件，使医生、诊所和医院工作人员能够 容易地从患者身上获得皮肤活检和皮肤水疱标本， 运送到参考实验室进行诊断解释， 或者用于比较在治疗性临床试验之前和期间获得的样品 2）研究皮神经的特性，以获得一种新的皮神经。 对正常和病变皮神经形态的认识 states.为实现这一目标，将努力实现以下具体目标： 第二个目的：a）检查正常人和那些 轻微神经病变，主要是糖尿病神经病变，以确定 皮肤活检和水疱方法的敏感性，B）研究 神经病患者皮肤神经的再生能力 化学和物理远端去神经支配，c）创建数据库， 皮肤活检和水疱分析的皮神经正常值 正常人的样本。 拟定商业应用： 在美国大约有1300万糖尿病患者， 其中大多数患有神经病。早期诊断对于 开始强化治疗以阻止神经病变进展。 几项临床试验正在进行中，用于治疗糖尿病 神经病变，没有确定患者受益的经证实的标准。在 此外，工人补偿个案亦不断增加， 需要客观评估神经损伤的程度这些 需要为活检套件创造商业市场， 一种客观的分析方法来评估皮肤神经疾病， 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.