Diabetic Peripheral NeuropathyPhase 2/3NCT01086150

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

A Phase 2/3 study testing Skin biopsy and Lidocaine 5% patches in people with Diabetic Peripheral Neuropathy, run by Albany Medical College at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Diabetic Peripheral Neuropathy
What is being tested?: Skin biopsy and Lidocaine 5% patches
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Oct 2015
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 13Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Albany Medical College
Albany, New York, 12208

Other trials in United States

About this study

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?

Conditions: Diabetic Peripheral Neuropathy
Being tested: Skin biopsy, Lidocaine 5% patches

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Skin biopsyProcedure or surgery
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% patchesDrug
Subject will apply patches to affected area QD for 12 hours then remove.

Study groups in NCT01086150
Study group	Role	What they receive
Healthy control patients	Other	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. Receives: Procedure: Skin biopsy; Drug: Lidocaine 5% patches
Type I or Type II diabetes with painful diabetic neuropathy	Other	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. Receives: Procedure: Skin biopsy; Drug: Lidocaine 5% patches
patients with non-painful diabetic peripheral neuropathy	Other	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. Receives: Procedure: Skin biopsy; Drug: Lidocaine 5% patches

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Scores From Composite Visual Analog Scale
Scores range from 0 to 10 with higher scores indicating higher levels of pain.
Measured: baseline, 4 weeks

Secondary outcomes (1)

Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP
Pixel intensity (0-256) of immunofluorescence for each individual biomarker.
Measured: Baseline, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Oct 2015

First posted12 Mar 2010 (estimated)
Study startOct 2009
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01086150
Sponsor's protocol ID: ENDO
Status last verified: May 2020
First submitted: 11 Mar 2010
Last updated: 11 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetic Peripheral Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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?
ClinicalTrials.gov ID: NCT01086150
Acronym / sponsor ID: ENDO
Conditions: Diabetic Peripheral Neuropathy
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Albany Medical CollegeUniversity, hospital or other
Collaborators: Endo USA Inc., a Keenova Therapeutics Company
Study start: Oct 2009
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 12 Mar 2010 (estimated)
Results: Posted 11 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Healthy control patients	Other	Procedure: Skin biopsy, Drug: Lidocaine 5% patchesSubjects 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.
Type I or Type II diabetes with painful diabetic neuropathy	Other	Procedure: Skin biopsy, Drug: Lidocaine 5% patches18 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.
patients with non-painful diabetic peripheral neuropathy	Other	Procedure: Skin biopsy, Drug: Lidocaine 5% patches18-70 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Skin biopsySkin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.	Procedure or surgery	Healthy control patients, Type I or Type II diabetes with painful diabetic neuropathy, patients with non-painful diabetic peripheral neuropathy
Lidocaine 5% patchesSubject will apply patches to affected area QD for 12 hours then remove.	Drug	Healthy control patients, Type I or Type II diabetes with painful diabetic neuropathy, patients with non-painful diabetic peripheral neuropathy

Primary outcome

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.

1 secondary outcome

Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP
Time frame: Baseline, 4 weeks

Results and safety

Results posted to the registry on 11 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Control Patients	11	11
Type I or Type II Diabetes With Painful Diabetic Neuropathy	27	21
Patients With Non-painful Diabetic Peripheral Neuropathy	13	12

Primary outcome: Pain Scores From Composite Visual Analog Scale

Time frame: baseline, 4 weeks. Mean (Full Range). Unit: units on a scale

Measure	Healthy Control Patients n = 0	Type I or Type II Diabetes With Painful Diabetic Neuropathy n = 21	Patients With Non-painful Diabetic Peripheral Neuropathy n = 12
Baseline	–	6.5 (4.5 to 9)	1.2 (0 to 3.1)
4 weeks	–	4.5 (0 to 8.9)	0.5 (0 to 1.5)

Population analysed: Healthy controls were not assessed for this measure.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Control Patients	0 of 11 (0%)	0 of 11 (0%)	Not reported
Type I or Type II Diabetes With Painful Diabetic Neuropathy	0 of 21 (0%)	0 of 21 (0%)	Not reported
Patients With Non-painful Diabetic Peripheral Neuropathy	0 of 12 (0%)	0 of 12 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Skin biopsy and Lidocaine 5% patches in people with Diabetic Peripheral Neuropathy, run by Albany Medical College at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Scores From Composite Visual Analog Scale (time frame: baseline, 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01086150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.