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

Use of Topical Lidocaine (Lidoderm 5% Patch) to Reduce Pain in Patients With Diabetic Neuropathy: Does the Density and Subtype of Sodium Channels Affect Response?

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 Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Procedure: Skin biopsy; Drug: Lidocaine 5% patches

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Healthy control patients; 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.	Procedure: Skin biopsy; Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.; Drug: Lidocaine 5% patches; Subject will apply patches to affected area QD for 12 hours then remove.
OTHER: Type I or Type II diabetes with painful diabetic neuropathy; 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.	Procedure: Skin biopsy; Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.; Drug: Lidocaine 5% patches; Subject will apply patches to affected area QD for 12 hours then remove.
OTHER: patients with non-painful diabetic peripheral neuropathy; 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.	Procedure: Skin biopsy; Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.; Drug: Lidocaine 5% patches; Subject will apply patches to affected area QD for 12 hours then remove.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores From Composite Visual Analog Scale	Scores range from 0 to 10 with higher scores indicating higher levels of pain.	baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP	Pixel intensity (0-256) of immunofluorescence for each individual biomarker.	Baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Albany Medical College
• Collaborators: Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: March 11, 2010
• First Submitted That Met QC Criteria: March 11, 2010
• First Posted (ESTIMATE): March 12, 2010

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Endo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO