Laser Therapy
Erchonia® EVRL™ for Peripheral Neuropathy
N/A
Recruiting
Research Sponsored by Erchonia Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Constant feet pain on-going over at least the past 3 months.
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.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline and 3 weeks
Awards & highlights
Study Summary
This trial will test whether the Erchonia EVRL machine can provide relief from foot pain caused by diabetic neuropathy.
Eligible Conditions
- Peripheral Neuropathy
- Diabetic Neuropathy
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been experiencing consistent foot pain for at least 3 months.
Select...
You can't take any pain medication for at least 6 hours before we measure your foot pain.
Select...
You have foot pain that scores 50 or higher on a 0-100 pain scale.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
Secondary outcome measures
Neuropathic Pain Symptom Inventory (NPSI)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Erchonia® EVRL™Active Control1 Intervention
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.
Group II: Placebo LaserPlacebo Group1 Intervention
The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light.
Find a site
Who is running the clinical trial?
Erchonia CorporationLead Sponsor
43 Previous Clinical Trials
1,935 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity of participants for this trial?
"Affirmative. Clinicaltrials.gov attests that this research, which was initially proposed on February 17th 2022, is actively looking for participants. A total of 64 individuals must be recruited from 3 distinct medical sites."
Answered by AI
Does enrollment in this project remain open to interested participants?
"Indeed, the clinical trial is looking for new participants. Initially posted on February 17th 2022 and freshly updated on August 1st 2022, 64 volunteers are needed from 3 medical centers to take part in this study."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
CiC Foot & Ankle
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1