18 and older, any sex, with Neuropathy, Diabetic or Neuropathy;Peripheral. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)Primary· Baseline and 3 weeks
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 represents a worse outcome.
For the primary study outcome, the overall study success is defined as a 35% or
Group
Value
95% CI
Erchonia® EVRL™
24
Placebo Laser
9
Satisfaction With Study OutcomeSecondary· Baseline and 3 weeks
At treatment endpoint, the subject was asked to rate how satisfied he or she was with any overall change in foot pain attained following the procedure administration phase with the Erchonia EVRL Laser, using the following five-point scale:
Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied
Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome.
Group
Value
95% CI
Erchonia® EVRL™
20
Placebo Laser
8
Four Weeks Post Procedure Change in Foot Pain Visual Analog Scale (VAS) ScoreSecondary· Baseline and 7 Weeks
The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score on the VAS indicates a greater level of pain, and a lower score indicates a lower level of pain.A decrease in the VAS pain rating indicates a reduction in foot pain and is positive for study success. An increase in the VAS pain rating indicates a worsening of foot pain and is negative for study success. The mean change in foot pain score recorded on the Visual Analog Scale (VAS) from baseline to 4 weeks post treatment was calculated for
Group
Value
95% CI
Erchonia® EVRL™
-34.32
± 33.61
Placebo Laser
-13.41
± 28.07
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT06912646 — Clinical Efficacy of the Erchonia EVRL for Providing Temporary Relief of Idiopathic Peripheral Neuropathy Foot Pain
· NA
· recruiting
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Other Erchonia Corporation trials
Trials by the same sponsor.
NCT06941610 — An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity
· NA
· recruiting
NCT06912646 — Clinical Efficacy of the Erchonia EVRL for Providing Temporary Relief of Idiopathic Peripheral Neuropathy Foot Pain
· NA
· recruiting
NCT06656325 — An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis
· NA
· recruiting
NCT05954065 — An Evaluation of the Effect of the Erchonia Laser for Non-invasive Reduction of Submental Fat
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NCT05674292 — An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring
· NA
· completed
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Sponsor: as reported to ClinicalTrials.gov by Erchonia Corporation
Last refreshed: 13 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05291975.