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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01086150
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Charles Argoff, Albany Medical College

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.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Procedure: Skin biopsy Drug: Lidocaine 5% patches Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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?
Study Start Date : October 2009
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.

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.




Primary Outcome Measures :
  1. Pain Scores From Composite Visual Analog Scale [ Time Frame: baseline, 4 weeks ]
    Scores range from 0 to 10 with higher scores indicating higher levels of pain.


Secondary Outcome Measures :
  1. Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP [ Time Frame: Baseline, 4 weeks ]
    Pixel intensity (0-256) of immunofluorescence for each individual biomarker.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086150


Locations
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United States, New York
Albany Medical College
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany Medical College
Endo Pharmaceuticals
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Responsible Party: Charles Argoff, MD, Albany Medical College
ClinicalTrials.gov Identifier: NCT01086150    
Other Study ID Numbers: ENDO
First Posted: March 12, 2010    Key Record Dates
Results First Posted: June 11, 2020
Last Update Posted: June 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action