An interventional study of Erchonia® EVRL™ and Placebo Laser in Neuropathy, Diabetic, Neuropathy;Peripheral and Neuropathy, Painful, sponsored by Erchonia Corporation. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Erchonia Corporation · Not applicable, Interventional, and Treatment
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.
Human Factors Validation Testing will initially be conducted to valuate a lay person's ability to understand and apply as applicable the information contained in the EVRL™ Use Device Proper Use Reference Guide, and device packaging and labeling materials to correctly, safely, and successfully activate and operate the EVRL™ to administer the treatment; and to identify any and all use difficulties, problems and errors, including those pertaining to critical tasks and close calls demonstrated by the lay person during device operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification, as applicable
Phase Two will commence following the successful completion of Phase One. Phase Two comprises the performance of a double-blind, randomized, placebo-controlled, clinical study of the efficacy of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Sponsor), for prescription home use application in providing temporary relief of diabetic peripheral neuropathy foot pain.
538 studies on the registry are indexed under Diabetic Neuropathies; 80 are open to participants now.
This study's enrollment of 64 is close to the median of 68 across 448 interventional studies indexed under Diabetic Neuropathies.
Browse Diabetic Neuropathies studies →Erchonia Corporation is the lead sponsor of 48 studies on the registry; 2 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The Erchonia® EVRL™ is made up of (1) 635 nanometers red laser diode and (1) 405 nanometers violet laser diode mounted in a portable handheld device.
Device: Erchonia® EVRL™
The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light.
Device: Placebo Laser
The Erchonia® EVRL™ is made up of (1) 635 nanometers red laser diode and (1) 405 nanometers violet laser diode mounted in a portable handheld device. The diodes are positioned approximately 3 to 6 inches from the top of the foot. The treatments will be self-administered by the subject at his or her's place of residence, two times per day for 21 days. Each procedure administration lasts 5 minutes per foot, for a total of 10 minutes.
The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light. The diodes are positioned approximately 3 to 6 inches from the top of the foot. The treatments will be self-administered by the subject at his or her's place of residence, two times per day for 21 days. Each procedure administration lasts 5 minutes per foot, for a total of 10 minutes.
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
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 greater difference between the proportion (number) of individual successes in each treatment group.
Time frame: Baseline and 3 weeks
Satisfaction With Study Outcome
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.
Time frame: Baseline and 3 weeks
Four Weeks Post Procedure Change in Foot Pain Visual Analog Scale (VAS) Score
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 each treatment group.
Time frame: Baseline and 7 Weeks
| Milestone | Erchonia® EVRL™ | Placebo Laser |
|---|---|---|
| Started | 33 | 31 |
| Completed | 33 | 27 |
| Not completed | 0 | 4 |
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 greater difference between the proportion (number) of individual successes in each treatment group.
| participants | Erchonia® EVRL™ | Placebo Laser |
|---|---|---|
| Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) | 24 | 9 |
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.
| participants | Erchonia® EVRL™ | Placebo Laser |
|---|---|---|
| Satisfaction With Study Outcome | 20 | 8 |
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 each treatment group.
| units on a scale | Erchonia® EVRL™ | Placebo Laser |
|---|---|---|
| Four Weeks Post Procedure Change in Foot Pain Visual Analog Scale (VAS) Score | -34.32 ± 33.61 | -13.41 ± 28.07 |
Collected over 7 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erchonia® EVRL™ | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Placebo Laser | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(years) | Erchonia® EVRL™ | Placebo Laser | Total |
|---|---|---|---|
| Mean | 67.39 ± 8.35 | 64.74 ± 9.08 | 66.10 ± 8.67 |
| Sex: Female, Male(Participants) | Erchonia® EVRL™ | Placebo Laser | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 18 | 16 | 34 |
| Race/Ethnicity, Customized(Participants) | Erchonia® EVRL™ | Placebo Laser | Total |
|---|---|---|---|
| Caucasian | 19 | 17 | 36 |
| Hispanic | 8 | 7 | 15 |
| African American | 2 | 6 | 8 |
| Asian / Pacific Islander | 1 | 1 | 2 |
| Other | 3 | 0 | 3 |
| Duration Since Onset of Foot Pain(months) | Erchonia® EVRL™ | Placebo Laser | Total |
|---|---|---|---|
| Mean | 93.33 ± 89.94 | 79.52 ± 97.63 | 86.64 ± 92.52 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2022 to primary completion in Oct 2024, 31 months.
Results were first posted in Aug 2025, 9 months after primary completion.
Of 152 interventional studies with no phase under Diabetic Neuropathies, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's 31 months is above that.
How these figures are worked out, and which studies are left out of them.
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