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Completed

NCT Number: NCT01086150

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

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.

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Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Albany Medical College

Albany, New York, 12208, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

skin biopsy

Procedure

Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.

Lidocaine 5% patches

Drug

Subject will apply patches to affected area QD for 12 hours then remove.

Primary outcomes

  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 outcomes

  1. Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP

    Time frame: Baseline, 4 weeks

    Pixel intensity (0-256) of immunofluorescence for each individual biomarker.

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Collaborators

  • Endo USA Inc., a Keenova Therapeutics Company

Registry information

Official study 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?

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2010
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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