NCT01086150

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?

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Albany Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-10-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2010-03-12
• Last updated: 2020-06-11
• Results posted: 2020-06-11

Locations

1 site across 1 country: United States