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?
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Albany Medical College
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Pain Scores From Composite Visual Analog Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
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.
Intervention: Skin biopsy (Procedure)
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.
Intervention: Lidocaine 5% patches (Drug)
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.
Intervention: Skin biopsy (Procedure)
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.
Intervention: Lidocaine 5% patches (Drug)
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.
Intervention: Skin biopsy (Procedure)
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.
Intervention: Lidocaine 5% patches (Drug)
Outcomes
Primary Outcomes
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
- Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP(Baseline, 4 weeks)
Investigators
Charles Argoff
MD
Albany Medical College