Trial Outcomes & Findings for Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain (NCT NCT05291975)
NCT ID: NCT05291975
Last Updated: 2025-08-13
Results Overview
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.
COMPLETED
NA
64 participants
Baseline and 3 weeks
2025-08-13
Participant Flow
Participant milestones
| Measure |
Erchonia® EVRL™
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.
Erchonia® EVRL™: 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.
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Placebo Laser
The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light.
Placebo Laser: 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.
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|---|---|---|
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Overall Study
STARTED
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33
|
31
|
|
Overall Study
COMPLETED
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33
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27
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain
Baseline characteristics by cohort
| Measure |
Erchonia® EVRL™
n=33 Participants
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.
Erchonia® EVRL™: 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.
|
Placebo Laser
n=31 Participants
The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light.
Placebo Laser: 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.
|
Total
n=64 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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67.39 years
STANDARD_DEVIATION 8.35 • n=5 Participants
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64.74 years
STANDARD_DEVIATION 9.08 • n=7 Participants
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66.10 years
STANDARD_DEVIATION 8.67 • n=5 Participants
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Sex: Female, Male
Female
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15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
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30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
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34 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Caucasian
|
19 Participants
n=5 Participants
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17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=5 Participants
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6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian / Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
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3 Participants
n=5 Participants
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0 Participants
n=7 Participants
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3 Participants
n=5 Participants
|
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Duration Since Onset of Foot Pain
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93.33 months
STANDARD_DEVIATION 89.94 • n=5 Participants
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79.52 months
STANDARD_DEVIATION 97.63 • n=7 Participants
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86.64 months
STANDARD_DEVIATION 92.52 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and 3 weeksThe 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.
Outcome measures
| Measure |
Erchonia® EVRL™
n=33 Participants
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.
Erchonia® EVRL™: 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.
|
Placebo Laser
n=31 Participants
The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light.
Placebo Laser: 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.
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|---|---|---|
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Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
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24 participants
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9 participants
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SECONDARY outcome
Timeframe: Baseline and 3 weeksAt 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.
Outcome measures
| Measure |
Erchonia® EVRL™
n=33 Participants
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.
Erchonia® EVRL™: 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.
|
Placebo Laser
n=31 Participants
The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light.
Placebo Laser: 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.
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|---|---|---|
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Satisfaction With Study Outcome
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20 participants
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8 participants
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SECONDARY outcome
Timeframe: Baseline and 7 WeeksPopulation: Five (5) participants in the active group and seven (7) participants in the placebo group did not return for the four (4)-week post-procedure follow-up visit. These participants were recorded as "Lost to Follow-up."
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.
Outcome measures
| Measure |
Erchonia® EVRL™
n=28 Participants
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.
Erchonia® EVRL™: 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.
|
Placebo Laser
n=24 Participants
The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light.
Placebo Laser: 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.
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|---|---|---|
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Four Weeks Post Procedure Change in Foot Pain Visual Analog Scale (VAS) Score
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-34.32 units on a scale
Standard Deviation 33.61
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-13.41 units on a scale
Standard Deviation 28.07
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Adverse Events
Erchonia® EVRL™
Placebo Laser
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place