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NCT05291975 · ClinicalTrials.gov registry record · NA

Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain

A NA study, sponsored by Erchonia Corporation.

Completed
Registry status
NA
Development phase
64
Enrollment target

NCT05291975: Completed NA study, sponsored by Erchonia Corporation.

NCT05291975 is a NA study that has completed, run by Erchonia Corporation. The registered enrollment target is 64 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.

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The verdict

NCT05291975, a NA study, has completed, sponsored by Erchonia Corporation.

COMPLETED
Registry status
NA
Development phase
64 participants
Enrollment target

Study Summary

The purpose of this clinical study is to determine the effectiveness of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Company), in providing prescription home use application for temporary relief of diabetic neuropathy foot pain in individuals diagnosed with diabetic neuropathy by a suitably qualified and licensed health professional.

Primary Outcome

The Visual Analog Scale (VAS) from baseline to endpoint (6 weeks) measurement is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represen

Interventions

  • DEVICE Placebo Laser
  • DEVICE Erchonia® EVRL™

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2022-02-17
Est. Completion 2024-12-12
Phase NA
Erchonia Corporation

34 total trials

What the finished NCT05291975 record still lists

NCT05291975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 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 2 interventions - of which Placebo Laser is the first listed.

NCT05291975 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05291975 about?

NCT05291975 is a clinical study titled "Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain". The purpose of this clinical study is to determine the effectiveness of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Company), in providing prescription home use application for temporary relief of diabetic neuropathy foot pain in individuals diagnosed with diabetic neuropathy by a...

What is the current status of trial NCT05291975?

This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2022-02-17. Estimated completion is 2024-12-12.

What interventions are being tested in trial NCT05291975?

The interventions under investigation include: Placebo Laser (DEVICE), Erchonia® EVRL™ (DEVICE).

Who is sponsoring clinical trial NCT05291975?

This trial is sponsored by Erchonia Corporation, which has 34 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05291975's enrollment target sits among peer trials

64 1147th of 2000 higher than 844 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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Source: ClinicalTrials.gov NCT05291975, the US trial registry maintained by the National Library of Medicine. NCT05291975 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.