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NCT06030297 · ClinicalTrials.gov registry record · NA
Diode Laser as a Biomarker for Neuropathic Pain of Peripheral Origin.
A NA study, sponsored by University of Utah.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
NCT06030297 is a NA study that has completed, run by University of Utah. The registered enrollment target is 75 participants.
The verdict
NCT06030297, a NA study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
Study Summary
The R61 will perform a four-part double-blind randomized crossover study transitioning from a pretreatment baseline phase, to randomized treatment with either lidocaine or an identical placebo patch, washout, and alternate arm. DLss measures will be obtained before and after each phase. Twice daily report of pain using a visual analogue scale will track severity of ongoing spontaneous pain in participants. The hybrid biomarker will distinguish between placebo and active treatment arms, will significantly correlate with extent of neuropathic pain reduction during lidocaine, but will not change during the placebo phase or no-treatment lead-in. If preset Go/No-Go criteria are met, the subsequent R33 validation will then compare lidocaine patch and placebo treatment in a blinded, randomized parallel arm study.
Interventions
- PROCEDURE Diode Laser fiber type Selective Stimulator
- DRUG ZTlido 1.8 % Topical System
- DIAGNOSTIC_TEST PeriCam PSI NR
- DIAGNOSTIC_TEST Medoc Quantitative Sensory Testing
- OTHER Inactive Topical System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2023-09-01 |
| Est. Completion | 2026-02-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06030297
The ClinicalTrials.gov registry entry for NCT06030297 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Diode Laser fiber type Selective Stimulator is the first listed.
NCT06030297 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06030297 about?
NCT06030297 is a clinical study titled "Diode Laser as a Biomarker for Neuropathic Pain of Peripheral Origin.". The R61 will perform a four-part double-blind randomized crossover study transitioning from a pretreatment baseline phase, to randomized treatment with either lidocaine or an identical placebo patch, washout, and alternate arm. DLss measures will be obtained before and after each phase. Twice daily ...
What is the current status of trial NCT06030297?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2023-09-01. Estimated completion is 2026-02-09.
What interventions are being tested in trial NCT06030297?
The interventions under investigation include: Diode Laser fiber type Selective Stimulator (PROCEDURE), ZTlido 1.8 % Topical System (DRUG), PeriCam PSI NR (DIAGNOSTIC_TEST), Medoc Quantitative Sensory Testing (DIAGNOSTIC_TEST), Inactive Topical System (OTHER).
Who is sponsoring clinical trial NCT06030297?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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