Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erchonia® EVRL™ | Active Comparator | 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. |
|
| Placebo Laser | Placebo Comparator | The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erchonia® EVRL™ | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CiC Foot & Ankle | Phoenix | Arizona | 85028 | United States | ||
| Laser Chiropractic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 20, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo Laser | Device | 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. |
|
| 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. | Baseline and 7 Weeks |
| West Covina |
| California |
| 91790 |
| United States |
| Cesar A. Lara M.D. Weight Loss & Wellness | Dunedin | Florida | 34698 | United States |
| FRANCO & CO Podiatric Medicine & Surgery | Miramar | Florida | 33025 | United States |
| FG001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Duration Since Onset of Foot Pain | The duration since onset of foot pain is recorded in months | Mean | Standard Deviation | months |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | Baseline and 3 weeks |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | participants | Baseline and 3 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | 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." | Posted | Mean | Standard Deviation | units on a scale | Baseline and 7 Weeks |
|
7 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 33 | 0 | 33 | 0 | 33 |
| EG001 | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs Manager | Erchonia Corporation | 8882420571 | tsammons@erchonia.com |
| Jun 16, 2025 |
| Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D009443 | Neuritis |
| C564945 | Neuropathy, Painful |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| Male |
|
| Hispanic |
|
| African American |
|
| Asian / Pacific Islander |
|
| Other |
|
|
|
| OG001 |
| 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. |
|
|