Clinical Efficacy and Human Factors Validation Testing for Prescription Home Use of the Erchonia Corporation EVRL™ for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain
Phase: NA
Conditions: Neuropathy, Diabetic, Neuropathy;Peripheral, Neuropathy, Painful
Sponsor: Erchonia Corporation

Erchonia® EVRL Relief from Diabetic Neuropathy Foot Pain Clinical Study Protocol: Clinical 
Efficacy Testing 
 
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Erchonia® EVRL 
 
A Placebo-Controlled, Randomized evaluation of the effect 
of the Erchonia® EVRL, manufactured by Erchonia 
Corporation (the Sponsor), for prescription home use 
application in providing temporary relief from diabetic 
neuropathy foot pain. 
 
 
 
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Appendix B: Clinical Efficacy Testing 
 
Revision # 
Description of Changes 
Approved by: 
Date 
1.0 
Original Protocol submitted for Q-Sub  
Travis Sammons 
September 9, 2021 
2.0 
Changes were made to accommodate 
satisfaction of Q-sub Q211922. Intended Use of 
device changed from OTC to Prescription Home 
Use. 
Travis Sammons 
January 20, 2022 
 
 
 

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TABLE OF CONTENTS 
 
 
STUDY INFORMATION ...............................................................................................2 
SPONSOR ...................................................................................................................2 
REGULATORY AND CLINICAL CONSULTANT ..........................................................2 
MONITOR ....................................................................................................................2 
PRINCIPAL CLINICAL INVESTIGATORS AND TEST SITES ......................................2 
PURPOSE OF STUDY ................................................................................................3 
EXPECTED RESULTS ................................................................................................3 
STUDY DESIGN ..........................................................................................................3 
SUBJECT GROUPS ....................................................................................................3 
DOUBLE BLIND DESIGN ............................................................................................4 
RANDOMIZATION .......................................................................................................4 
SUBJECTS ..................................................................................................................4 
STUDY PROCEDURE .................................................................................................6 
STUDY TEST BATTERY .............................................................................................6 
BASELINE VARIABLES...............................................................................................6 
OUTCOME ASSESSMENT TOOLS ............................................................................6 
PRIMARY OUTCOME MEASURE: ..............................................................................6 
SECONDARY OUTCOME MEASURES ......................................................................7 
STUDY PROCEDURE PROTOCOL ............................................................................8 
STUDY QUALIFICATION ............................................................................................8 
SIGNING OF INFORMED CONSENT FORM ..............................................................8 
ASSIGNMENT OF SUBJECT IDENTIFICATION NUMBER .........................................8 
STUDY QUALIFICATION CHECKLIST ........................................................................8 
PRE-TREATMENT EVALUATION PHASE ..................................................................9 
TREATMENT ADMINISTRATION PROTOCOL ......................................................... 10 
TREATMENT ADMINISTRATION PHASE MEASURES ............................................ 10 
POST-TREATMENT ACTIVITIES .............................................................................. 10 
ADVERSE EVENTS .................................................................................................. 11 
PRIVACY AND CONFIDENTIALITY .......................................................................... 11 
MONITORING OF THE CLINICAL STUDY ................................................................ 11 
STATISTICAL ANALYSIS .......................................................................................... 11 
CASE REPORT FORMS ........................................................................................... 17 
 
 
APPENDIX D: EVRL PROPER USE REFERENCE GUIDE 
APPENDIX K: NEUROPATHIC PAIN SYMPTOM INVENTORY (NPSI) 
APPENDIX L: RESEARCH SUBJECT INFORMATION AND CONSENT FORM 
APPENDIX M: CASE REPORT FORMS 
 
 
 
 
 
 
 

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STUDY INFORMATION 
 
SPONSOR 
Erchonia Corporation 
112 Southchase Blvd.  
Fountain Inn, SC 29644 
Contact: Travis Sammons 
Telephone: 888-242-0571 ext. 7510 
E-mail: tsammons@erchonia.com 
www.erchonia.com 
  
REGULATORY AND CLINICAL CONSULTANT 
219 East Harbor 
Hendersonville, TN 37075 
Contact: Elvira Cawthon, BS, MS, EMT-P  
Principal Consultant 
Telephone: 615-879-9875 
E-mail: cawthonconsulting@outlook.com 
 
MONITOR 
Erchonia Corporation 
112 Southchase Blvd.  
Fountain Inn, SC 29644 
Contact: Travis Sammons  
Telephone: 888-242-0571 ext. 7510 
E-mail: tsammons@erchonia.com 
www.erchonia.com 
 
PRINCIPAL CLINICAL INVESTIGATORS AND TEST SITES 
Test Site #1: Dr. Kerry Zang, DPM 
10214 N. Tatum Boulevard, #B300 
Phoenix, AZ 85028 
Telephone: 602.954.0777 
E-mail: kerryzang@aol.com  
 
Test Site #2:  Dr. Sandra Franco, DPM 
Franco & Co Podiatry MedSpa 
2407 Main Street 
Miramar, Florida 33025 
Telephone: 954.436.7400 
E-mail: sfranco@francoandcompany.com 
 
Test Site #3: Cesar Lara, M.D 
Dr. Cesar Lara Center for Age and Weight Management 
2323 Curlew Road, Suite 1A 
Dunedin, Florida 34698 
Telephone: 727.446.3021 
E-mail: clara@cesarlaramd.com 
  
 
 

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Test Site #4: Dr. Kirk Gair, DC 
Laser Chiropractic 
1901 W Pacific Ave #205 
West Covina, CA 91790 
Telephone: 626.338.3600 
E-mail: drgair@gmail.com 
 
INSTITUTIONAL REVIEW BOARD 
WIRB Copernicus Group (WCG) 
1019 39th Avenue SE Suite 120 
Puyallup, WA 98374-2115 
Phone: 1-855-818-2289 
IRB Tracking Number: 20220447 
E-mail: clientcare@wcgclinical.com 
www.wcgclinical.com 
 
PURPOSE OF STUDY 
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.  
 
EXPECTED RESULTS 
Following completion of the study treatment administration protocol with the Erchonia® EVRL, it is 
anticipated that compared to baseline, at least 35% more subjects in the test group than in the 
placebo group will show a 30% or greater reduction in self-reported VAS pain rating in the feet at 
study endpoint evaluation relative to baseline. 
 
STUDY DESIGN 
This clinical study is a prospective, double blind, placebo-controlled, randomized design evaluation 
of the effect of the Erchonia® EVRL for prescription home use application in providing temporary 
relief of diabetic neuropathy foot pain. 
 
SUBJECT GROUPS  
Subjects enrolled in the clinical study will not have been enrolled in the Human Factors Validation 
Testing study. 
 
Each enrolled subject will be randomized to the active treatment group or to the placebo treatment 
group of the clinical study, as follows: 
 
Active treatment group: Subjects randomized to the active treatment group will self-administer the 
study treatments with the active (true) Erchonia® EVRL laser in his or her own home.  
 
Placebo treatment group: Subjects randomized to the placebo treatment group will self-administer 
the study procedures with a ‘fake’ (placebo) Erchonia® EVRL laser in his or her own home.   
The ‘fake’ (placebo) laser device will appear to the subject to be an active device but will not produce 
any therapeutic light output. The placebo laser device is designed to have the same physical 
appearance as the actual (active) laser device, including the appearance of any visible and invisible 
light output. Therefore, both the active and placebo devices emit light when activated that is 
indistinguishable to the subject. As the laser light does not put out any notable degree of heat or 
noise, these are also not distinguishing factors for subjects between the active and placebo devices.  

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Regardless of whether the subject self-administers the study treatments with the actual or the fake 
laser device, all subjects will be required to adhere to all phases of the entire protocol design. 
 
DOUBLE BLIND DESIGN  
This clinical study is a double-blind design, such that neither the subject nor the investigator is 
aware of whether the subject has been provided with the active or the placebo Erchonia® EVRL 
device. Unblinding will occur after the final data set has been fully analyzed  
 
The blinding procedure is as follows:  
 
1) Each subject is randomly assigned to Treatment Group A or to Treatment Group B. Subjects 
assigned to Treatment Group A will receive the Erchonia® EVRL A and subjects assigned to 
Treatment Group B will receive the Erchonia® EVRL B. Only one individual employee at the 
study Sponsor site will know which label (‘A’ or ‘B’) corresponds to the actual (active) EVRL 
device and which label corresponds to the ‘fake’ device until the final study data set analysis is 
complete. That individual will ensure that this information is stored and maintained confidentially 
at the Sponsor’s work site.  
2) The fake (placebo) Erchonia® EVRL is designed to have the same physical appearance as the 
actual Erchonia® EVRL, including the appearance of any visible and invisible light output. 
Therefore, both the test and placebo devices emit light when activated that is indistinguishable 
to both the subject and to the investigator. As the laser light does not put out any notable degree 
of heat or noise, these are not distinguishing factors for subjects between the two groups. 
 
RANDOMIZATION 
Subject randomization occurs following attainment of subject consent. Subject allocation to 
treatment group will be via variable block randomization with varying block sizes of two, four and 
six used at random to minimize the likelihood of predicting the next treatment group assignment. 
 
Randomization will be attained using computer generation sequence methodology, ensuring that 
the randomization methodology and the generated allocation sequence is concealed from the 
subjects.  
 
Concealment will be insured as follows: 
 
(ii) Each computer-generated randomization sequence is unique and will therefore not be able to 
be replicated. 
(iii) Randomization will occur to either ‘Treatment Group A’ or to ‘Treatment Group B’ rather than to 
a test or placebo group, and only one designated individual at the Sponsor site will know which 
assignment (A or B) corresponds to the active device and which corresponds to the fake device. 
Unblinding will not occur until the final study data set analysis is complete. 
 
SUBJECTS  
 
Recruitment 
Subjects will be recruited from online advertisements for individuals who have been previously 
diagnosed with diabetes induced peripheral neuropathy by a suitably qualified and licensed health 
professional.  
 
Compensation  
A subject who completes his or her participation in this clinical study through to the final post-
treatment administration will receive financial compensation of $200. 

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A subject will not be charged for the cost of the study treatments with the Erchonia® EVRL Laser 
or for the cost of any other directly-related evaluations or measurements that occur as part of his or 
her participation in the study. 
 
Sample size  
There will be 64 qualified subjects enrolled in this clinical study: 
 
32 subjects in the active treatment group 
32 subjects in the po treatment group 
 
Rationale for sample size 
Based on the following parameters established for the purposes of assessing efficacy of the 
Erchonia® EVRL in this clinical study …: 
 
¾ Individual subject success criteria defined as a 30% or greater reduction in self-reported Degree 
of Pain rating on the 0-100 VAS from baseline to study endpoint evaluation.  
 
N.B.: The clinical relevance of a 30% change in VAS score is explained and supported in the 
STATISTICAL ANALYSIS PLAN section further along in this protocol document. 
 
¾ Overall study success criteria of at least a 35% difference between the active device group and 
the placebo device group, comparing the proportion of individual successes in each group.  
¾ It is anticipated that about 55% of subjects in the active device group and about 20% of subjects 
in the placebo device group will meet the individual success criteria, and 
¾ intended application of a two-tailed test with an alpha value of 0.05 and Power of 0.8 
 
…the sample size of 29 subjects per group (active group and placebo group, separately) has 
been determined using the following reference calculator: Hypothesis Testing: Categorical Data 
- Estimation of Sample Size and Power for Comparing Two Binomial Proportions in Bernard 
Rosner's Fundamentals of Biostatistics. 
 
For the purposes of sample size calculation, it is anticipated that about one-twentieth of subjects 
overall may withdraw from the study prior to completion for various reasons. Therefore, the following 
formula is used to determine the final needed starting sample size for each group: 
 
Final sample size = sample size X 1/(1-d); where d = # expected dropouts/# subjects enrolled. 
Final sample size = 29 X 1/(1-0.083) 
Final sample size = 29 X 1/0.917 = 29 X 1.0905 = 31.62, rounded to 32 subjects per treatment 
group. 
 
Therefore, a minimum starting sample size of 32 subjects in each treatment group is needed to 
ensure that sufficient numbers remains at the end of the trial (29 subjects per group) for any 
significant differences found between groups to be considered statistically valid and representative 
of the general population being sampled. This results in a total of 64 subjects being enrolled in this 
study across both study treatment groups.  
 
 
 
 
 

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STUDY PROCEDURE
STUDY TEST BATTERY
The following are the study assessment tools to be used and the variables to be recorded in this 
clinical study.
BASELINE VARIABLES
A. Neuropathy Variables
¾ Number of months/years since onset of foot pain.
¾ Number of months/years since diabetes diagnosis
¾ Insulin dependency 
B. Medication and Treatment 
¾
Current medication for diabetic peripheral neuropathy foot pain: Record all medications 
currently used for the management of neuropathy pain symptoms. 
¾
Prior treatment approaches for diabetic peripheral neuropathy foot pain: Record all prior 
treatments, whether conventional or alternative.
¾
Concomitant Medication and Therapy Use: Record all over-the-counter and prescription 
medications currently used for any indication (other than the management of neuropathy pain 
symptoms)
C.
Subject Demographics: Subject age, gender and ethnicity are recorded.
OUTCOME ASSESSMENT TOOLS
PRIMARY OUTCOME MEASURE:
VISUAL ANALOG SCALE (VAS) DEGREE OF PAIN RATING: Subjects will be asked to rate the 
overall degree of pain experienced in their feet on the following 0-100 mm (0 -10 cm) Visual Analog 
Pain Scale, by responding to the following question:
“Using the scale below, please mark with a cross (X) the spot along the 0 to 100 line below that 
best shows how much pain you feel in your feet right now. ‘0’ means you feel no pain at all and 
‘100’ means you feel the worst pain imaginable. Please mark only one spot. Do not think of or 
write in a number.”  
no pain 
                                              worst pain imaginable
The Visual Analog Pain Scale (VAS) is one of the three most commonly used scales for assessing 
chronic pain. It is a simple scale that consists of a line anchored at one end by a label such as "NO 
PAIN" and at the other end "WORST POSSIBLE PAIN". The subject marks on the line the spot for 
the pain intensity, which is then measured.
Like a thermometer, this means that its two ends are rooted, and a doubling of the score does 
accurately reflect a doubling of the pain. Consequently, sensitive t-tests and ANOVA methods can 

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be used in the analysis, so that significant differences can be identified with relatively small sample 
sizes or small differences between groups.  
Source: Measuring Pain by Adrian White, Acupuncture in Medicine, November 1998 – Vol 16 No. 2 
 
To participate in the study the subject agrees to refrain from consuming any pain relief medication 
within 6 hours of recording a required VAS Degree of Pain Rating to ensure that the effect of the 
pain relief medication does not influence any potential treatment effect of the study treatment with 
the Erchonia® EVRL as evidenced through the VAS ratings.  
 
 
SECONDARY OUTCOME MEASURES 
 
NEUROPATHIC PAIN SYMPTOM INVENTORY (NPSI): The NPSI was developed in 2004 by 
Bouhassira Didier to evaluate the different symptoms of neuropathic pain in adults. It is a 12-item 
self-administered patient-reported outcome (PRO) assessment tool with a recall/ observation period 
of over the past 24 hours. It contains 10 descriptors representing 5 distinct dimensions on the basis 
of factor analysis: burning pain, deep pain, paroxysmal pain, evoked pain, paresthesia/dysesthesia, 
and 2 temporal items designed to assess pain duration and the number of pain paroxysms. The 
NPSI has been validated in patients with definite neuropathic pain of peripheral or central origin.  
 
The development and validation of the NPSI is contained in the abstract below: 
 
Development and validation of the Neuropathic Pain Symptom Inventory. 
Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-
Minet M, Collin E, Grisart J, Boureau F. 
Pain. 2004 Apr;108(3):248-57. 
 
This study describes the development and validation of the Neuropathic Pain Symptom Inventory 
(NPSI), a new self-questionnaire specifically designed to evaluate the different symptoms of 
neuropathic pain. Following a development phase and a pilot study, we generated a list of 
descriptors reflecting spontaneous ongoing or paroxysmal pain, evoked pain (i.e. mechanical and 
thermal allodynia/hyperalgesia) and dysesthesia/paresthesia. Each of these items was quantified 
on a (0-10) numerical scale. The validation procedure was performed in 176 consecutive patients 
with neuropathic pain of peripheral (n = 120) or central (n = 56) origin, recruited in five pain centers 
in France and Belgium. It included: (i) assessment of the test-retest reliability of each item, (ii) 
determination of the factorial structure of the questionnaire and analysis of convergent and 
divergent validities (i.e. construct validity), and (iii) evaluation of the ability of the NPSI to detect the 
effects of treatment (i.e. sensitivity to change). The final version of the NPSI includes 10 descriptors 
(plus two temporal items) that allow discrimination and quantification of five distinct clinically 
relevant dimensions of neuropathic pain syndromes and that are sensitive to treatment. The 
psychometric properties of the NPSI suggest that it might be used to characterize subgroups of 
neuropathic pain patients and verify whether they respond differentially to various pharmacological 
agents or other therapeutic interventions. 
PMID: 15030944 
 
The full article and the NPSI Assessment tool are contained in Appendix K of this clinical study 
protocol.  
 
 
 
 

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Subject Satisfaction With Study Outcome 
The subject is asked to rate how satisfied he or she is with any change in his or her overall foot pain 
following completion of the laser administration procedures with the Erchonia® EVRL by using the 
5-point Likert scale presented below to respond to the following question: “Overall, how satisfied or 
dissatisfied are you with any change in your foot pain following the study procedures with the study 
laser device?”  
x Very Satisfied 
x Somewhat Satisfied 
x Neither Satisfied nor Dissatisfied 
x Not Very Satisfied 
x Not at All Satisfied   
 
BLINDING EFFICACY EVALUATION TOOLS 
 
Subject Perceived Group Allocation and Rationale 
The subject records whether he or she believes to have received the study treatments with the true 
or fake Erchonia® EVRL and records verbatim his or her reasoning or rationale for this perceived 
determination. 
 
 
STUDY PROCEDURE PROTOCOL 
 
STUDY QUALIFICATION 
 
SIGNING OF INFORMED CONSENT FORM 
The investigator will commence by presenting and reviewing in detail the items in the informed 
consent form with the individual and answer any questions. To proceed, the individual must willingly 
sign the informed consent form. 
 
ASSIGNMENT OF SUBJECT IDENTIFICATION NUMBER 
The subject is assigned to a unique subject identification number based upon his or her order of 
entry into the study. 
 
Additional information about the informed consent and subject ID number assignment is contained 
in a later section of the protocol titled, “SAFETY AND CONFIDENTIALITY ISSUES.” 
 
SUBJECT RANDOMIZATION TO TREATMENT GROUP  
Following signing of the consent form and prior to study qualification evaluation, a subject is 
randomly assigned to Treatment Group A or to Treatment Group B, following the methodology 
outlined above in the STUDY DESIGN section of the protocol. 
 
STUDY QUALIFICATION CHECKLIST 
To be eligible for study participation, a subject must satisfy the following qualification criteria: 
 
INCLUSION CRITERIA 
 
To be eligible for study participation, a subject must satisfy each of the following criteria. 
 
¾ Previously diagnosed with diabetes induced peripheral neuropathy by a suitably qualified and 
licensed health professional within the past 6 months. 

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¾ Over the age of 18 years. 
¾ Able to read and write English.  
¾ Constant feet pain on-going over at least the past 3 months.  
¾ If using analgesics (pain medication), 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. 
The subject may elect to decrease analgesic use during the study. Cannabis prescribed for 
medicinal purposes would qualify as an analgesic in this context. 
¾ 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. 
¾ 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. 
¾ 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  
 
A subject who satisfies any of the following criteria will be excluded from study participation: 
 
¾ Pregnant or think they might be pregnant. 
¾ Open wounds (sores, cuts, ulcers, etc.) around the feet 
¾ Cancerous growths around the feet. 
¾ 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. 
 
PRE-TREATMENT EVALUATION PHASE 
 
The pre-treatment evaluation phase commences following successful study qualification.  
 
BASELINE VARIABLES 
 
¾ Baseline Foot Variables 
¾ Medication and Treatment 
¾ Insulin Dependency 
¾ Subject Demographics 
 
PRE-TREATMENT OUTCOME ASSESSMENTS  
 
¾ Visual Analog Scale (VAS) Degree of Foot Pain Rating  
¾ Neuropathic Pain Symptom Inventory (NPSI) 
 
The Pre-Treatment Outcome assessments will serve as the Baseline data set. 
 
 

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AT-HOME TREATMENT ADMINISTRATION PHASE 
 
A fully qualified enrolled subject will be provided either a Erchonia® EVRL A or B device based on 
his or her randomization to treatment group (see Randomization). Additionally, the enrolled subject 
will be provided the EVRL Proper Use Reference Guide (Appendix D) and applicable Case Report 
Forms (Appendix M) for capturing study outcome assessments. 
 
TREATMENT ADMINISTRATION PROTOCOL   
   
¾ The treatment administration phase extends over 3 consecutive weeks.  
¾ The subject self-administers two treatment administrations with the Erchonia® EVRL (A or 
B) on each consecutive day of the 3-week treatment administration phase for a total of 42 
self-administered treatments. 
¾ Each treatment administration lasts 5 minutes per foot, for a total of 10 minutes. 
¾ Each treatment is self-administered by the subject in his or her own home. 
 
 
TREATMENT ADMINISTRATION PHASE MEASURES 
The following treatment administration phase measures will be recorded by the subject at home 
through the provided Case Report Forms (Appendix M). 
 
10 DAY EVALUATION 
Following 10 days of study treatment administrations (20 treatment administrations) with the 
Erchonia® EVRL (approximately halfway through the treatment administration phase), the following 
will be recorded on the provided case report forms by the subject at home.  
 
¾ Visual Analog Pain Scale (VAS) Degree of Foot Pain Rating 
 
3 WEEK EVALUATION: STUDY ENDPOINT 
 
Following completion of the entire 3 weeks of study treatment administrations with the Erchonia® 
EVRL, the following will be recorded on the provided case report forms by the subject at home as 
outlined in the STUDY TEST BATTERY section above. These recordings will form the study 
endpoint data set from which change from baseline will be evaluated with respect to assessing 
study outcome 
 
¾ Visual Analog Pain Scale (VAS) Degree of Foot Pain Rating 
¾ Neuropathic Pain Symptom Inventory (NPSI) 
¾ Subject Satisfaction With Study Outcome 
¾ Perceived Treatment Group 
 
 
 
 
POST-TREATMENT ACTIVITIES 
   
7 WEEK EVALUATION: 4 Weeks Post-Treatment  
 
Four weeks following the completion of the 3-week treatment administration phase, the following 
will be recorded on the provided case report forms by the subject at home, as outlined in the STUDY 
TEST BATTERY section above. 

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¾ Visual Analog Pain Scale (VAS) Degree of Foot Pain Rating 
¾ Neuropathic Pain Symptom Inventory (NPSI) 
¾ Subject Satisfaction With Study Outcome 
¾ Perceived Treatment Group 
 
COMPLIANCE ASSESSMENT LOG 
The subject will record each day when they have administered a treatment with the Erchonia® 
EVRL Laser.  
 
CHANGE IN MEDICATION RECORD SHEET 
If at any time during the treatment and/or post-treatment administration phases the subject has a 
change in his or her medication use (cessation of prior medication, change in dosage/frequency of 
use of a current medication, addition of a new medication) the subject will record the medication 
name, dose/frequency of use, expected duration of medication use, and the reason for the change 
in the Change in Medication Record Sheet. 
 
ADVERSE EVENTS  
It is unlikely and not expected that any adverse events will result from implementation of this clinical 
study protocol. Prior clinical trials using low level laser light have not typically yielded any adverse 
events or reactions. However, potential adverse events that may feasibly occur from application of 
the Erchonia® EVRL include, but are not necessarily limited to skin irritation, discoloring, rash, 
indentations, and infection. 
 
PRIVACY AND CONFIDENTIALITY 
Records for each subject in this clinical study will be maintained in separate files in a locked filing 
cabinet at the respective test site. The investigator at the test site will be responsible for ensuring 
that all records for a subject pertaining to his or her participation in the clinical study are maintained 
in the subject’s file at all times other than when information is being recorded on them.   
 
Copies of all subject case report forms will be made and supplied to the study statistician and 
Erchonia Corporation who will each maintain these copies in a separate clinical study file that is 
kept in a locked filing cabinet on their respective premises. The original records will be maintained 
at the respective test sites.  
 
Subjects’ identities will be kept confidential by assigning each subject a unique de-identified subject 
ID upon acceptance into the study. The subject ID will comprise the investigator’s two initials (first 
and last name initials) and a three-digit number that will be based upon the subject’s order of entry 
into the clinical study. For example, under Study Investigator John Black, the third subject enrolled 
in the study would have a subject ID of JB003. 
 
MONITORING OF THE CLINICAL STUDY 
A Clinical Trial Monitoring Plan will be in place to ensure on-going compliance and accuracy of 
procedures throughout the trial. 
 
 
STATISTICAL ANALYSIS 
 
STUDY ANALYSIS POPULATIONS 
 
(i) 
Intent-to-Treat (ITT) Population  

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The Intent-to-Treat (ITT) analysis population is defined as all consented and enrolled 
subjects. The ITT population will comprise the principal population analysis for 
evaluation of study primary efficacy outcome.  
 
 
(ii) Per Protocol Population  
 
The per protocol analysis population is defined as all consented and enrolled 
subjects who completed the entire clinical study per protocol, inclusive of all 
treatment administrations and all study activities and assessments per protocol 
without missing data or major protocol deviations. The per protocol population will 
comprise the secondary population analysis of the study primary efficacy outcome to 
provide support for the principal ITT population analysis as well as for all secondary 
outcome assessments.  
 
HANDLING OF MISSING DATA 
Based on over twenty-five (25) years of experience conducting comparable clinical trials 
through the study Sponsor, Erchonia Corporation, the relatively small sample size, the 
short duration of the trial, and the minimal requirements and commitments required from 
enrolled subjects, it is anticipated that withdrawal and lost-to-follow-up rates will be 
minimal and so will be missing data. Therefore, the single imputation methodology is 
selected as that to be implemented to account for any missing data. Single imputation 
methodology is applicable to impute missing values when a dataset is small, the number 
of missing values is small, the missing data is assumed to be Missing Completely at 
Random (MCAR), and outcome analysis procedures are simple. The single imputation 
methodology selected for this study is whichever is more conservative of the mean or the 
median of the variable for the treatment group from which the missing data emanated. 
 
 
BASELINE RECORDINGS 
 
SAMPLE DEMOGRAPHICS 
Sample demographics recorded at Baseline assessment will be summarized descriptively by 
treatment group, using mean, standard deviation, median and range (minimum, maximum) for the 
continuous variable of subject age in years, and by number (N) and percentage (%) for the 
categorical sample variables of gender and ethnicity. Sample demographics will be compared for 
differences between treatment groups and test sites. Any identified differences will be explored with 
respect to potential impact on study outcome. 
 
NEUROPATHY VARIABLES 
Sample neuropathy continuous variables recorded at Baseline assessment of months since 
diagnosis of diabetes, and months since onset of peripheral neuropathy foot pain will be 
summarized descriptively by treatment group, using mean, standard deviation, median and range 
(minimum, maximum). The categorical Baseline neuropathy variable of presence or absence of 
insulin dependency will be summarized descriptively by number (N) and percentage (%) per 
category. Sample demographics will be compared for differences between treatment groups and 
test sites. Any identified differences will be explored with respect to potential impact on study 
outcome. 
 
MEDICATION AND TREATMENT  

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The below medication and treatment usage as recorded at Baseline assessment will be 
summarized categorically by, and compared between, treatment groups using number (N) and 
percentage (%):  
(i) Current medications taken for relief of diabetic foot pain 
(ii) Prior treatment approaches for relief of diabetic foot pain 
(iii) Concomitant medication and therapy use: non-pain relief indications  
 
 
PRIMARY EFFICACY OUTCOME MEASURE: CHANGE IN SUBJECT SELF-REPORTED VAS 
PAIN RATING FROM BASELINE TO STUDY ENDPOINT   
 
Primary efficacy outcome measure for this clinical study will be a statistically significant difference 
in the proportion of subjects between active and placebo treatment groups who achieve a clinically 
meaningful and statistically significant decrease in self-reported VAS pain rating from Baseline (pre-
treatment) to study Endpoint (Week 3).    
 
The principal primary efficacy outcome evaluation will be performed for the study intent-to-treat 
(ITT) population according to the following pre-determined primary efficacy success criteria. 
 
Individual Subject Success Criteria 
Individual subject success criteria is defined as a 30% or greater decrease in self-reported 
pain rating on the 0 to 100 Visual Analog Scale (VAS) at study Endpoint (Week 3) relative to 
Baseline. 
 
Overall Study Success Criteria.  
Overall study success criteria defined as at least a 35% difference between treatment groups, 
comparing the proportion of individual successes in each group. It is anticipated that about 55% of 
subjects in the active treatment group will meet the individual success criteria and about 20% of 
subjects in the placebo treatment group will meet the individual success criteria.  
 
The clinical relevance of a 30% change in VAS score has been well established by FDA’s Division 
of Physical Medicine and Rehabilitation Devices. The following Erchonia Corporation light therapy 
devices (Product Code NHN) obtained FDA 510(k) clearance based on clinical trials employing the 
30% VAS change as the primary efficacy endpoint for pain reduction: 
 
1. K221987; 09/01/22: “Erchonia® GVL: is indicated while using the green and violet diode 
simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and 
shoulder pain of musculoskeletal origin.” 
 
2. K191257; 08/08/19: “Erchonia® EVRL: is indicated while using the red and violet diode 
simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and 
shoulder pain of musculoskeletal origin.”  
2. K180197; 5/21/18; “Erchonia® FX-635: is indicated for the following two indications: 
a. as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin. 
b. as an adjunct to reducing chronic heel pain arising from plantar fasciitis.” 
 
3. K132940; 04/14/14: “The Erchonia Allay laser is indicated as an adjunct to reducing chronic hell 
pain arising from plantar fasciitis.” 
 

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4. K012580; 01/17/02: “The TUCO Erchonia PL2000 is indicated for adjunctive use in providing 
temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.” 
 
Evaluation Time Point 
The study end evaluation time point at which primary study success will be analyzed is at three 
weeks post-baseline, following completion of the 42nd and final study treatment administration with 
the Erchonia® EVRL.   
 
Hypotheses 
The pre-established null and alternative hypotheses for the primary efficacy outcome evaluation 
were the following: 
 
(i) Null Hypothesis: The difference in the proportion of individual subject successes between the 
active and placebo treatment groups will be less than 35%. 
 
Ho: µA - µP < 35% 
 
Where ‘A’ = active treatment group; and ‘P’ = placebo treatment group  
 
(ii) Alternative Hypothesis: The difference in the proportion of individual successes between the 
active and placebo treatment groups will be 35% or greater in favor of the active treatment 
group. 
 
H1: µA - µP  35% 
 
Where ‘A’ = active treatment group; and ‘P’ = placebo treatment group  
 
(i) Responder Rate Analysis 
Principal determination of study primary outcome success as defined will be according to 
Responder Rate Analysis calculated by determining the percentage of individual subject successes 
in each of the active and placebo treatment groups, separately, and then subtracting the two 
proportions to attain the difference in proportions between the two treatment groups. Overall Study 
6XFFHVVZLOOEHGHPRQVWUDWHGLIWKLVGLIIHUHQFHLVLQIDYRURIWKHKLJKHUSURSRUWLRQRFFXUULQJ
for the active treatment group. 
 
(ii) Chi-Squared Analysis of Proportions 
 
A chi-squared analysis to assess the significance of the difference in the proportion of individual 
subject successes (Responder Rate) between the active and placebo treatment groups will be 
performed. A two-tailed significance level of 5% will be considered statistically significant. 
 
(iii) ANCOVA of Mean Change in Diabetic Peripheral Neuropathy Foot Pain VAS  Ratings  
 
Parametric Analysis of Covariance (ANCOVA) with the mean change from Baseline to study 
Endpoint (Week 3) in diabetic peripheral neuropathy foot pain ratings on the 0-100 VAS as the 
dependent variable, treatment group as the independent variable of interest, and Baseline diabetic 
peripheral foot pain VAS rating as a covariate will be performed. A two-tailed significance level of 
5% was predetermined to be considered statistically significant.  
 
SECONDARY EFFICACY OUTCOMES  
 

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The following secondary efficacy outcomes will be evaluated to provide support for the primary 
efficacy outcome analysis. As no claims are intended to be made based on the secondary 
efficacy outcome evaluations, secondary efficacy outcome analysis will be performed for 
the per protocol analysis population only and statistical analyses will not be performed; 
secondary efficacy outcomes data will be presented descriptively only. 
 
(i) 
Diabetic Peripheral Neuropathy Foot Pain VAS Ratings Across Study Progression 
 
 
Descriptives of mean, standard deviation (SD), median, and range (minimum, maximum) will be 
presented in a table for the degree of pain ratings recorded on the 0-100 VAS for diabetic peripheral 
neuropathy pain at each of the four (4) study assessments of Baseline (pre-treatment), Day 10 
(Post-Baseline), Endpoint (3 Weeks Post-Baseline), and Follow-Up (7 Weeks Post-Baseline - 4 
Weeks Post-Treatment End) by treatment group. 
  
(ii) Neuropathic Pain Symptom Inventory (NPSI) Scores Across Study Progression 
 
Descriptives of the mean, standard deviation (SD), median and range (minimum, maximum) for 
each of the five (5) dimension scores on the NPSI and the Total NPSI score will be presented in a 
table for each of the three study assessments of Baseline, Endpoint (Week 3), and Follow-Up 
(Week 7) by treatment group.  
 
 
 
SATISFACTION WITH STUDY OUTCOME RATINGS 
Subject satisfaction scores will be presented descriptively in a table as number (N) and percentage 
(%) per response category (Very Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, 
Not Very Satisfied, Not at All Satisfied) at each assessment of Study Endpoint (Week 3) and Study 
Follow-Up (Week 7) by treatment group.  
 
Ratings will be further categorized into ‘positive satisfaction responses’ by summing the ‘very 
satisfied’ and ‘somewhat satisfied’ categories. The proportion of ‘positive satisfaction responses’ in 
each category at each assessment visit between treatment groups will be compared using a chi-
squared analysis with a two-tailed significance level of 5% considered statistically significant.  
 
Additionally, Spearman’s correlation analysis will be conducted to assess the relationship between 
subject satisfaction with treatment outcome ratings and mean change in subject VAS ratings for  
diabetic peripheral neuropathy foot pain from Baseline to study Endpoint (Week 3), and from 
Baseline to Follow-Up (Week 7) assessments. 
 
CHANGES IN MEDICATION USE AND TREATMENT COMPLIANCE 
Subject compliance with treatment administration and maintenance of medication use reported at 
baseline without change across study duration will be assessed and reported descriptively based on 
subject recordings on the Subject Daily Diary.     
 
BLINDING EFFICACY EVALUATION  
 
Blinding efficacy evaluation will be conducted through analysis of findings from the Subject 
Perceived Subject Group Allocation and Rationale responses, recorded at completion of the 
treatment administration phase (study endpoint). 
 
Statistical evaluation of blinding efficacy will be performed as follows: 

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(i) The number (N) and percentage (%) of subjects who correctly perceived their treatment group 
assignment and the percentage of subjects who did not correctly perceive their treatment group 
assignment will be calculated for each treatment group. 
 
(ii) A Chi-Squared Analysis to assess the significance of the difference in the proportion of 
subjects who accurately perceived their Baseline treatment group assignment between the 
active and placebo treatment groups at each of Endpoint (Week 3) and Follow-Up (Week 7) 
assessments will be performed. A two-tailed significance level of 5% will be considered 
statistically significant. 
 
 
(i) Qualitative analysis confirmation: Evaluation of the comments provided by the subject in the 
rationale section to explain the guess at group assignment will be evaluated and interpreted as 
follows to either support or negate the numerical findings:   
 
¾ Positive blinding efficacy will be supported through qualitative assessment of comments 
provided to support perceived group assignment that pertain to the determination being 
based on treatment efficacy or lack thereof, e.g.: ‘My foot pain is much less than it used to 
be, so I believe I got the real treatment’ or ‘My foot pain hasn’t really changed, so I believe 
I got the fake treatment.’ 
 
¾ Blinding will be determined to have failed if comments provided to support perceived group 
assignment pertain to factors such as sensation/visual clues or overhearing conversations 
by research staff members. 
 
INDIVIDUAL SUBJECT VAS RATINGS ACROSS STUDY DURATION 
Individual subject data for the Primary Outcome Measure of diabetic peripheral neuropathy foot pain 
VAS Ratings as recorded at each of Baseline (pre-treatment) and Study Endpoint (Week 3) 
assessments, by Treatment Group, by Test Site, will be presented in table format. 
 
INDIVIDUAL TEST SITE DATA 
Key demographic and neuropathy variables and the primary outcome assessment for the ITT 
analysis population will be presented by treatment group by each of the four individual test sites 
participating in this study. Data will be presented in descriptive format only due to the small sample 
sizes that preclude statistical conclusions from being validly drawn. 
 
SAFETY ANALYSES  
Safety analyses will be based on all subjects who were randomized to the test or to the placebo 
treatment group. Safety will be assessed by evaluating and comparing frequency and incidence of 
observed and/or reported adverse events between test and placebo treatment groups. A chi-square 
test with a continuity correction will be performed to compare the percentage of subjects who had 
adverse events between test and placebo treatment group subjects.  
 
INFORMED CONSENT 
x Informed consent will be an agreement between the individual investigator and each subject, 
having the capacity to understand and make an informed decision. Consent will be obtained prior 
to each potential subject’s participation in this clinical study. 

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x Each subject participating in this clinical study will be made aware of the fact that his or her 
participation involves research and the intent of the research, the expected duration of his or her 
participation and a description of the procedures that will be followed.   
x Each subject will be made aware of the reasonably expected benefits he or she might receive, 
as well as any risks or potential discomfort that are involved.   
x Each subject will also be made aware of alternative treatments available to him or her.   
x Each subject will be made aware that his or her records will remain confidential, but that the FDA 
and the IRB has the right to inspect his or her records.   
x Each subject will be told that his or her participation in the clinical study is voluntary, without force 
or influence from the investigator or sponsor. 
x Each subject will be given the name and method of contacting the appropriate person(s) to 
answer his or her questions about the research and in the event of a research-related injury. 
 
The informed consent form that will be used to collect the data from each subject in this clinical 
study can be found in Appendix L. 
 
CASE REPORT FORMS 
 
The case report forms that will be used to collect the data from each subject in this clinical trial 
can be found in Appendix M. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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RESEARCH SUBJECT INFORMATION AND CONSENT FORM 
 
 
TITLE: 
A placebo-controlled, randomized, double-blind evaluation of the 
effect of the Erchonia® EVRL™ for prescription home use application 
in providing temporary relief from diabetic peripheral neuropathy foot 
pain.   
 
PROTOCOL NO.: 
R-DPN 
 
WIRB® Protocol # 
 
SPONSOR: 
Erchonia Corporation 
 
INVESTIGATOR: 
 
 
 
 
STUDY-RELATED 
PHONE NUMBER(S): 
 
 
 
 
This consent form is being provided to you and may be discussed with family or friends before 
making your decision. This consent form may contain words that you do not understand. Please 
ask the study investigator in person, or during a teleconference or videoconference to explain any 
words or information that you do not clearly understand. 
 
SUMMARY 
You are being asked to be in a research study. The purpose of this consent form is to help you decide 
if you want to be in the research study. Please read this form carefully. To be in a research study you 
must give your informed consent. “Informed consent” includes: 
x 
Reading this consent form, 
x 
Having the investigator explain the research study to you, 
x 
Asking questions about anything that is not clear. 
 
You should not join this research study until all of your questions are answered. 
Things to know before deciding to take part in a research study: 
x 
The main goal of a research study is to learn things to help patients in the future. 
x 
The main goal of regular medical care is to help each patient. 
x 
No one can promise that a research study will help you. 
x 
Taking part in a research study is entirely voluntary. No one can make you take part. 

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x 
If you decide to take part, you can change your mind later on and withdraw from the 
research study. 
x 
This study involves experimental (investigational) device procedures that are being tested 
for a certain condition or illness. An investigational device is one that has not been 
approved by the U.S. Food & Drug Administration (FDA). 
After reading and discussing the information in this consent form you should know: 
x 
Why this research study is being done; 
x 
What will happen during the research; 
x 
What device and procedures will be used; 
x 
Any possible benefits to you; 
x 
The possible risks to you; 
x 
The other medical procedures, drugs or devices that could be used instead of being in this 
research study; and 
x 
How problems will be treated during the study and after the study is over. 
 
If you take part in this research study, you will be given a copy of this signed and dated consent 
form. 
 
PURPOSE OF THE STUDY 
In this study, the Sponsor, Erchonia Corporation, is studying the use of a device called the Erchonia® 
EVRL™ that gives off low level laser light. This study is to see if using the Erchonia® EVRL™ can 
help to relieve the chronic pain arising from diabetic peripheral neuropathy. The use of the Erchonia® 
EVRL™ in this study is investigational, as the EVRL™ has not been cleared for market by the FDA 
for relieving pain associated with neuropathy foot pain. 
 
 
PROCEDURES 
¾ If you agree to take part in this study, you will be one of about 64 people taking part. 
¾ This is a randomized, placebo-controlled study. This means that if you choose to take part in 
this study, it will be determined by chance (like the flip of a coin) whether you will get the 
active study treatment or the placebo study treatment. In this study, there will be two groups 
of participants. Participants in one of the groups will get active study treatments. The other 
group of participants will get placebo treatments.  
 
Since there are two different groups, you have: 
 
¾ About a 50% chance of receiving active study treatments. 
¾ About a 50% chance of receiving a placebo treatment  

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Neither the active nor the placebo device make any noise or produce any heat, and both will 
have a light that you can see, so you will be able to guess which group you are in. 
 
If you are currently utilizing prescribed pain medicine, to take part in this study you must agree 
to not make changes to current prescribed analgesic regimen, however you may elect to 
decrease the pain medication use during the study. 
 
¾ The study takes about 7 weeks to complete. 
¾ The study process is as follows: 
 
 
SCREENING  
If you are interested in taking part in this research study, we will conduct in office visit or a 
remote call to determine if you are eligible for the study. The office visit or screening call will 
last 10-15 minutes. 
 
PRE-PROCEDURE EVALUATION PHASE 
On the same day as the screening, if you are eligible for the study, we will ask you to:   
x 
provide information about your neuropathy pain and about treatments you may have tried 
to relieve your foot pain associated with diabetic neuropathy. 
x 
provide information on any medication you may currently be taking.  
x 
rate how painful your foot pain is to you at that time on a scale from 0 to 100, where ‘0’ 
means ‘no pain’ and ‘100’ means ‘worst pain imaginable.’  
x 
fill out a questionnaire about different symptoms of your foot pain 
x 
provide information about your age, gender, and ethnicity. 
The pre-procedure evaluation takes about 15 minutes to complete. 
 
  
AT-HOME TREATMENT PHASE (3 WEEKS) 
The at-home study treatment phase will start once you have successfully completed the 
screening and pre-procedure evaluation. The at-home study treatment phase will last 3 weeks. 
The process you will go through during the at-home treatment phase is as follows: 
¾ You will be shipped a Erchonia EVRL™ laser and operation manual (instructions for 
use). 
¾ You will need to administer treatments with the Erchonia EVRL™ during the at-home 
treatment phase by following the instructions contained in the Proper Use and 
Reference Guide.  
¾ You will need to administer the treatments with the Erchonia EVRL™, twice a day for 3 
weeks (42 total treatments). Each treatment is applied 5 minutes per foot for a total of 
10 minutes. 

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¾ You will need to record each time you administer a treatment. 
¾ You cannot do any other treatments to help with your foot pain during the at-home 
study treatment phase.  
 
TREATMENT PHASEAT HOME EVALUATION FORMS (DAY 10, DAY 21) 
There are two at home evaluation forms you must complete during the 3 Week study treatment 
phase:  
1) at the end of the first 10 days of the treatment phase, and; 
2)  at the end of the 3-week treatment phase.  
 
At each of these two evaluation points, you must refrain from taking any pain medicine at 
least 6 hours prior to completing the evaluation forms. The forms will ask you to:   
x 
rate how painful your foot pain is to you at that time on a scale from 0 to 100, where ‘0’ 
means ‘no pain’ and ‘100’ means ‘worst pain imaginable.’  
The 3-week evaluation form will also ask you to: 
x 
fill out a questionnaire about different symptoms of your foot pain 
x 
rate how satisfied you are with the outcome of the treatment administration with the 
Erchonia® EVRL™ Laser on a five-point scale. 
x 
record whether you believe you received treatments with the actual EVRL™ laser or the 
fake EVRL ™ device and why you think this. 
 
Each of the two evaluation forms take about 5-10 minutes to complete.  
 
ADDITIONALLY, DURING THE 3-WEEK STUDY TREATMENT PHASE: 
• we may contact you by phone or e-mail about once a week to see how things are going; and 
• ask you to record any change of medication that is made during the treatment phase.: 
 
4 WEEK POST-PROCEDURE EVALUATION 
The 4-week post procedure evaluation will take place 4 weeks after you have finished the 3-
week treatment phase. During this time, you must continue to not do any other treatments to 
help with your foot pain including treatments with the Erchonia® EVRL™.  
For the 4-week post-procedure evaluation, you must refrain from taking any pain medicine at 
least 6 hours prior to completing the evaluation form to: 
• rate how painful your foot pain is to you at that time on a scale from 0 to 100, where ‘0’ means 
‘no pain’ and ‘100’ means ‘worst pain imaginable.’  
• fill out a questionnaire about different symptoms of your foot pain 
• rate how satisfied you are with the outcome of the treatment administration with the Erchonia® 
EVRL™ Laser on a five-point scale. 

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• record whether you believe you received treatments with the actual EVRL™ laser or the fake
EVRL™ device and why you think this.
   The 4-week post-treatment online evaluation takes about 15-20 minutes. 
RISKS AND DISCOMFORTS 
The complete risk profile or anticipated risks with the use of the Erchonia® EVRL™ laser device 
is not known. However, there may be risks to using the device with this study procedure such as 
skin irritation, itching, discoloring, rash, indentations, pain/discomfort, and infection.  
It is possible that you will not get any improvement in your foot pain or that they may even 
worsen. 
Women who are pregnant or nursing a child may not take part in this study.  
NEW INFORMATION  
You will be told about any new information that might change your decision to be in this study. 
You may be asked to sign a new consent form if this occurs. 
BENEFITS 
Your foot pain may lessen while you are in this study; however, this cannot be promised. The 
results of this study may help people to relieve foot pain associated with diabetic peripheral 
neuropathy in the future. 
COSTS 
It will not cost you anything to be part of the study. Erchonia Corporation, the sponsor of this 
research will provide use of the Erchonia® EVRL™ laser device to do the study treatment free 
of charge during this study. The cost for all study related procedures and measurements will 
also be covered by Erchonia Corporation. Nothing will be billed to you or to your insurance 
company. 
PAYMENT FOR PARTICIPATION   
If you finish the study, after the final 4-week post procedure, you will be paid $200 for your part 
in this research study. 
ALTERNATIVE TREATMENT  
If you decide not to enter this study, there is other care available to you, such as over-the-
counter medicines like aspirin, ibuprofen, naproxen, acetaminophen, and capsaicin; topical 
creams such as lidocaine, salicylate and cortisone; prescription medications such as Celebrex, 
Lodine, and Relafen; antidepressants; anti-seizure drugs; opioid medicines, local anesthetic 
injections; surgical procedures; electrical nerve stimulation therapy; and hand or foot braces or 
orthopedic shoes. You do not have to be in this study to be treated for your foot pain. 
COMPENSATION FOR INJURY 
If you are injured or get sick from being in this study, call your doctor immediately.  Your 
insurance will be billed for this treatment.  The sponsor will pay any charges that your insurance 
does not cover. No other payment is routinely available from the sponsor. 

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AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH PURPOSES 
 
What information may be used and given to others? 
 
The study investigator will get your personal and medical information. For example: 
 
x 
Research records 
x 
Records about your study visits. 
 
Who may use and give out information about you? 
 
The study investigator and the study staff. 
 
Who might get this information? 
 
The sponsor of this research.  “Sponsor” means any persons or companies that are: 
x 
working for or with the sponsor, or 
x 
owned by the sponsor 
 
Your information may be given to:  
x 
The U.S. Food and Drug Administration (FDA), 
x 
Department of Health and Human Services (DHHS) agencies, 
x 
WCG IRB. 
 
Why will this information be used and/or given to others? 
x 
to do the research, 
x 
to study the results, and 
x 
to see if the research was done right 
 
If the results of this study are made public, information that identifies you will not be used. 
 
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
May I review or copy my information? 
Yes, but only after the research is over. 

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May I withdraw or revoke (cancel) my permission? 
Yes, but this permission will not stop automatically. 
You may withdraw or take away your permission to use and disclose your health information at 
any time. You do this by sending written notice to the study investigator. If you withdraw your 
permission, you will not be able to stay in this study. 
 
When you withdraw your permission, no new health information identifying you will be gathered 
after that date. Information that has already been gathered may still be used and given to others. 
 
Is my health information protected after it has been given to others? 
There is a risk that your information will be given to others without your permission. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time. 
 
VOLUNTARY PARTICIPATION AND WITHDRAWAL 
Your participation in this study is voluntary. You may decide not to participate, or you may leave 
the study, at any time.  Your decision will not result in any penalty or loss of benefits to which 
you are otherwise entitled. 
Your participation in this study may be stopped at any time by the sponsor without your consent 
for any of the following reasons: 
x 
if it is in your best interest; 
x 
you do not consent to continue in the study after being told of changes in the research that 
may affect you; 
x 
or for any other reason.  
 
SOURCE OF FUNDING FOR THE STUDY 
The sponsor, Erchonia Corporation, will pay for this research study. 
 
 
 
 

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QUESTIONS 
Contact (PI Name) at (telephone number) (24 hours) for any of the following reasons: 
x 
if you have any questions about this study or your part in it,   
x 
if you feel you have had a research-related injury or a bad reaction to the study treatment, 
or 
x 
if you have questions, concerns, or complaints about the research. 
 
If you have questions about your rights as a research subject or if you have questions, concerns, 
or complaints about the research, you may contact: 
 
WCG IRB 
1019 39th Avenue SE Suite 120 
Puyallup, Washington 98374-2115 
Telephone:  855-818-2289 
E-mail: researchquestions@wcgirb.com 
 
WIRB is a group of people who independently review research. 
WIRB will not be able to answer some study-specific questions, such as questions about 
appointment times.  However, you may contact WIRB if the research staff cannot be reached or 
if you wish to talk to someone other than the research staff.  
Do not sign this consent form unless you have had a chance to ask questions and have gotten 
satisfactory answers. 
If you agree to be in this study, you will receive a signed and dated copy of this consent form for 
your records. 
 
 
 
 
 
 
 

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CONSENT 
I have read this consent form (or it has been read to me).  All my questions about the study and 
my part in it have been answered. I freely consent to be in this research study. 
I authorize the use and disclosure of my health information to the parties listed in the 
authorization section of this consent for the purposes described above.  
By signing this consent form, I have not given up any of my legal rights. 
 
__________________________________________ 
Subject Name (printed) 
 
CONSENT SIGNATURE: 
 
________________________________________ 
__________________ 
Signature of Subject (18 years and older) 
Date 
 
 
________________________________________ 
__________________ 
Signature of Person Conducting Informed 
Date 
Consent Discussion 

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AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH 
PURPOSES  
Who might get this information? 
The sponsor of this research.  “Sponsor” means any persons or companies that are: 
x working for or with the sponsor, or  
x owned by the sponsor. 
Your information may be given to:  
x The U.S. Food and Drug Administration (FDA), 
x Department of Health and Human Services (DHHS) agencies, 
x Governmental agencies in other countries, 
x Institutional Review Board (IRB)  
x A 
description 
of 
this 
clinical 
trial 
will 
be 
available 
on 
http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not 
include information that can identify you. At most, the Web site will include 
a summary of the results. You can search this Web site at any time. 
Why will this information be used and/or given to others? 
x to do the research,  
x to study the results, and  
x to see if the research was done right.   
 
If the results of this study are made public, information that identifies you will not 
be used. 
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
 
 

Erchonia® EVRL™ Relief from Diabetic Neuropathy Foot Pain Clinical Study: RESEARCH 
SUBJECT INFORMATION AND CONSENT FORM 
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May I review or copy my information? 
Yes, but only after the research is over.  
May I withdraw or revoke (cancel) my permission? 
This permission will be good until December 31, 2060. 
You may withdraw or take away your permission to use and disclose your health 
information at any time. You do this by sending written notice to the study 
investigator.  If you withdraw your permission, you will not be able to stay in this 
study. 
When you withdraw your permission, no new health information identifying you 
will be gathered after that date.  Information that has already been gathered may 
still be used and given to others.   
Is my health information protected after it has been given to others? 
There is a risk that your information will be given to others without your 
permission. 
 
__________________________________________ 
Subject Name (printed) 
 
CONSENT SIGNATURE: 
 
________________________________________ __________________ 
Signature of Subject (18 years and older) 
Date 
 
________________________________________ __________________ 
Signature of Person Conducting Informed 
Date 
Consent Discussion