Your session is about to expire
← Back to Search
Procedure
Lidocaine Patch for Peripheral Neuropathy (DLss Trial)
N/A
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Objective 1 (Stanford): No complaints of peripheral neuropathy or other foot pain
Objective 1 (Stanford): 18 - 70 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
DLss Trial Summary
This trial will compare a lidocaine patch to a placebo patch to see if the lidocaine patch helps reduce neuropathic pain. Measurements and a visual scale will track pain severity. The study will also assess a hybrid biomarker to distinguish between active and placebo treatments.
Who is the study for?
This trial is for adults with peripheral neuropathy or neuralgia from non-acute causes like diabetes, pre-diabetes, or injury. Participants must be aged 18-70 and not have a medical history of conditions or medications that cause neuropathy. They can't join if they're allergic to lidocaine, currently on chemotherapy, taking certain heart drugs, have acute neuropathy issues like Guillain-Barre Syndrome, severe liver disease, or bleeding problems.Check my eligibility
What is being tested?
The study tests the effectiveness of a lidocaine patch versus a placebo in reducing pain for those with peripheral neuropathy. It's a double-blind crossover study where participants switch between treatments. Pain levels are tracked daily using visual scales and special equipment measures changes before and after each phase.See study design
What are the potential side effects?
Possible side effects may include skin reactions at the patch application site such as redness or irritation due to lidocaine or other components in the topical system.
DLss Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have foot pain or numbness.
Select...
I am between 18 and 70 years old.
Select...
I am 18 or older with long-term nerve pain or pain from plantar fasciitis or an ankle sprain.
Select...
I am 18 or older with long-term nerve pain from conditions like diabetes or after chemotherapy, and my pain is significant.
Select...
I have no history of diseases or medication use that could cause nerve damage.
DLss Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area of neurogenic flare response (mm squared) following repetitive subthreshold diode laser stimulation.
CMi:Aδ ratio of amperage for sensory perception threshold following diode laser stimulation
DLss Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Neuropathy assessment and biomarker testing (Utah)Experimental Treatment3 Interventions
History, physical, and neurological exam Nerve conduction study Medical record review of neuropathy history PROMIS pain severity and interference testing Brief pain inventory Norfolk quality of life questionnaire Quantitative sensory testing 3mm skin punch biopsy Diode laser testing of C:Aδ ratio Non-invasive speckle imaging
Group II: Biomarker Optimization (Stanford)Experimental Treatment3 Interventions
Screening for neuropathy, foot problems and diabetes Diode laser testing of C:Aδ ratio Non-invasive speckle imaging Quantitative sensory testing ZTlido 1.8% lidocaine patch testing in some subjects
Group III: Crossover testing in participants with painful neuropathy (ZTlido 1.8% lidocaine patch)Active Control4 Interventions
History, physical, and neurological exam Nerve conduction study Medical record review of neuropathy history PROMIS pain severity and interference testing Brief pain inventory Norfolk quality of life questionnaire Quantitative sensory testing 3mm skin punch biopsy Diode laser testing of C:Aδ ratio Non-invasive speckle imaging ZTlido 1.8% lidocaine patch application to both feet for 7 days up to 12 hours per day.
Group IV: Crossover testing in participants with painful neuropathy (placebo patch)Placebo Group4 Interventions
History, physical, and neurological exam Nerve conduction study Medical record review of neuropathy history PROMIS pain severity and interference testing Brief pain inventory Norfolk quality of life questionnaire Quantitative sensory testing 3mm skin punch biopsy Diode laser testing of C:Aδ ratio Non-invasive speckle imaging Placebo patch application to both feet for 7 days up to 12 hours per day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diode Laser fiber type Selective Stimulator
2018
N/A
~50
Find a Location
Who is running the clinical trial?
Stanford UniversityOTHER
2,395 Previous Clinical Trials
17,341,049 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
1 Patients Enrolled for Peripheral Neuropathy
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,288 Total Patients Enrolled
2 Trials studying Peripheral Neuropathy
272 Patients Enrolled for Peripheral Neuropathy
University of UtahLead Sponsor
1,100 Previous Clinical Trials
1,778,600 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
205 Patients Enrolled for Peripheral Neuropathy
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial encompass adults aged 18 or older?
"In accordance with the study's inclusion criteria, interested parties must fall within an age bracket of 18 to 69 years old."
Answered by AI
Is the research team currently enrolling participants for this experiment?
"The information on clinicaltrials.gov diplomatically attests to the fact that this study is actively enrolling participants, with its original posting dating back to November 1st 2022 and most recent updates being from September 5th 2023."
Answered by AI
Are there specific qualifications to be eligible for participation in this research?
"This clinical trial is recruiting up to 301 individuals who suffer from peripheral neuropathy and are within the age range of 18-69."
Answered by AI
How many volunteers are enrolled in this clinical trial?
"Affirmative. Clinicaltrials.gov data suggests that this clinical trial, which was published on November 1st 2022, is still searching for participants. Specifically, 301 volunteers are needed from 2 different medical centres."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger