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

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Skin biopsy
Lidocaine 5% patches
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Albany Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Healthy control patients

Type I or Type II diabetes with painful diabetic neuropathy

patients with non-painful diabetic peripheral neuropathy

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Pain Scores From Composite Visual Analog Scale
Scores range from 0 to 10 with higher scores indicating higher levels of pain.

Secondary Outcome Measures

Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP
Pixel intensity (0-256) of immunofluorescence for each individual biomarker.

Full Information

First Posted
March 11, 2010
Last Updated
May 27, 2020
Sponsor
Albany Medical College
Collaborators
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01086150
Brief Title
Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy
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 Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
Collaborators
Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy control patients
Arm Type
Other
Arm Description
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 Title
Type I or Type II diabetes with painful diabetic neuropathy
Arm Type
Other
Arm Description
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 Title
patients with non-painful diabetic peripheral neuropathy
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Skin biopsy
Intervention Description
Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.
Intervention Type
Drug
Intervention Name(s)
Lidocaine 5% patches
Intervention Description
Subject will apply patches to affected area QD for 12 hours then remove.
Primary Outcome Measure Information:
Title
Pain Scores From Composite Visual Analog Scale
Description
Scores range from 0 to 10 with higher scores indicating higher levels of pain.
Time Frame
baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP
Description
Pixel intensity (0-256) of immunofluorescence for each individual biomarker.
Time Frame
Baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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