Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Group 1: 18-70 years of age, non-diabetic with no nervous system disease (healthy control group)
Group 2: 18-70 years of age with Type I or Type II diabetes with significantly painful diabetic neuropathy (VAS > 40mm at Baseline)
Group 3: 18-70 years of age with Type I or Type II diabetes with non- painful or insignificantly painful diabetic neuropathy (VAS < 40mm at Baseline)

Exclusion Criteria

History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator
Allergy to lidocaine
Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
Women who are pregnant, breastfeeding or trying to become pregnant
History of slow-healing diabetic foot ulcers
Current skin or soft tissue lesions on the foot that will interfere with application of the lidocaine patch and or skin biopsies
Subjects taking Class I antiarrhythmics
HgA1c > 11%
Active cancer within the previous two years except treated basal cell carcinoma of the skin
Co-morbidities that can produce neuropathy
Subjects taking sodium channel blockers within one week of study treatment and throughout the study
Subjects taking any other experimental drugs within 30 days prior to Screening Visit (Visit 1)
Application of lidocaine patch to either foot within two weeks of Screening Visit (Visit 1)

Arm && Interventions

Group	Intervention	Description
Type I or Type II diabetes with painful diabetic neuropathy	Skin biopsy	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.
Healthy control patients	Skin biopsy	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.
Healthy control patients	Lidocaine 5% patches	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.
Type I or Type II diabetes with painful diabetic neuropathy	Lidocaine 5% patches	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.
patients with non-painful diabetic peripheral neuropathy	Skin biopsy	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.
patients with non-painful diabetic peripheral neuropathy	Lidocaine 5% patches	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.