Conditions: Diabetic Peripheral Neuropathy
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 51
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. arm 2: 18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. arm 3: 18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study.

Interventions: intervention 1: Skin biopsy intervention 2: Lidocaine 5% patches
Intervention descriptions: intervention 1: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. intervention 2: Subject will apply patches to affected area QD for 12 hours then remove.

Protocol document: