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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: Completed NA study, sponsored by University of Utah.
NCT06030297 is a NA study that has completed, run by University of Utah. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants' will report sensory threshold and pain threshold following diode laser stimulation to foot dorsum of ascending power as measured by amperage.
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 |
What the finished NCT06030297 record still lists
NCT06030297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Diode Laser fiber type Selective Stimulator is the first listed.
NCT06030297 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06030297's enrollment target sits among peer trials
75 1069th of 2000 higher than 919 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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