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
