The purpose of this study is to see if an investigational drug known as the lidocaine 5% patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how topical lidocaine affects the nerve endings, and to determine whether treatment with the lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in subjects who did not report pain at the start of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.
Subject will apply patches to affected area QD for 12 hours then remove.
Albany Medical College
Albany, New York, United States
Pain Scores From Composite Visual Analog Scale
Scores range from 0 to 10 with higher scores indicating higher levels of pain.
Time frame: baseline, 4 weeks
Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP
Pixel intensity (0-256) of immunofluorescence for each individual biomarker.
Time frame: Baseline, 4 weeks
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