Neuropathy, Diabetic, Neuropathy, Painful, Neuropathy;Peripheral
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICEErchonia® 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.
DEVICEPlacebo 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.
Sponsors
Erchonia Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously diagnosed with diabetes induced peripheral neuropathy by a suitably qualified and licensed health professional within the past 6 months * Over the age of 18 years of age * Able to read and write English. * Constant feet pain on-going over at least the past 3 months. * If using analgesics (pain medication), you must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14 days prior to enrollment; and willing and able to not have planned upward dose titration of analgesics during the study period. You may elect to decrease analgesic use during the study. Cannabis prescribed for medicinal purposes would qualify as an analgesic in this context. * Willing and able to refrain from engaging in any non-study procedure therapies for the management of foot pain throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture. * Agrees to refrain from taking a dosage of analgesic (pain medication) for at least 6 hours before a scheduled VAS foot pain rating is to be recorded. * Subjects' degree of foot pain on the 0-100 VAS, with 0 being no pain and 100 being worst pain imaginable, is 50 or greater.
Exclusion criteria
* Pregnant or think you might be pregnant. * Open wounds (sores, cuts, ulcers, etc) around the feet * Cancerous growths around the feet * Difficulty with hand dexterity sufficient to impact ability to administer treatments with the laser such as from severe arthritis in the hands, Multiple Sclerosis, Cerebral Palsy, Parkinson's Disease, Huntington's Disease, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) | 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 greater difference between the proportion (number) of individual successes in each treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Study Outcome | 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. |
| Four Weeks Post Procedure Change in Foot Pain Visual Analog Scale (VAS) Score | 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 each treatment group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| 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. | 31 |
| Total | 64 |
Baseline characteristics
| Characteristic | Erchonia® EVRL™ | Placebo Laser | Total |
|---|---|---|---|
| Age, Continuous | 67.39 years STANDARD_DEVIATION 8.35 | 64.74 years STANDARD_DEVIATION 9.08 | 66.10 years STANDARD_DEVIATION 8.67 |
| Duration Since Onset of Foot Pain | 93.33 months STANDARD_DEVIATION 89.94 | 79.52 months STANDARD_DEVIATION 97.63 | 86.64 months STANDARD_DEVIATION 92.52 |
| Race/Ethnicity, Customized African American | 2 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian / Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 19 Participants | 17 Participants | 36 Participants |
| Race/Ethnicity, Customized Hispanic | 8 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 18 Participants | 16 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 31 |
| other Total, other adverse events | 0 / 33 | 0 / 31 |
| serious Total, serious adverse events | 0 / 33 | 0 / 31 |
Outcome results
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.
Time frame: Baseline and 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erchonia® EVRL™ | Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) | 24 participants |
| Placebo Laser | Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) | 9 participants |
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.
Time frame: Baseline and 7 Weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erchonia® EVRL™ | Four Weeks Post Procedure Change in Foot Pain Visual Analog Scale (VAS) Score | -34.32 units on a scale | Standard Deviation 33.61 |
| Placebo Laser | Four Weeks Post Procedure Change in Foot Pain Visual Analog Scale (VAS) Score | -13.41 units on a scale | Standard Deviation 28.07 |
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.
Time frame: Baseline and 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erchonia® EVRL™ | Satisfaction With Study Outcome | 20 participants |
| Placebo Laser | Satisfaction With Study Outcome | 8 participants |