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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

Must not have

Objective 2 and 3: Taking exclusionary medications related to lidocaine, or with anti-arrhythmic properties, such as tocainide or mexilitine

Objective 2 and 3: Severe liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have foot pain or numbness.

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I am between 18 and 70 years old.

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I am 18 or older with long-term nerve pain or pain from plantar fasciitis or an ankle sprain.

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I am 18 or older with long-term nerve pain from conditions like diabetes or after chemotherapy, and my pain is significant.

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I have no history of diseases or medication use that could cause nerve damage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking medications like lidocaine or those for irregular heartbeat.

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I have severe liver disease.

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I am currently undergoing chemotherapy.

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I have a condition or take medication that could cause nerve damage.

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I have a bleeding disorder or a history of severe bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Group IV: Crossover testing in participants with painful neuropathy (placebo patch)Placebo Group4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diode Laser fiber type Selective Stimulator

2018

N/A

~50

0 / 10Eligibility criteria met