Erchonia EVRL for Peripheral Neuropathy

Overseen By Travis Sammons

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Erchonia Corporation

Must be taking: Analgesics

Disqualifiers: Diabetes, Pregnancy, Open wounds, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a handheld laser device called the Erchonia® EVRL™ to determine its effectiveness in reducing foot pain in individuals with idiopathic peripheral neuropathy, a condition with unknown nerve damage causes. Individuals who have experienced constant foot pain for at least three months and have been diagnosed with this type of neuropathy may qualify to participate. The goal is to assess whether this laser treatment can provide temporary pain relief without altering current pain medication routines. As an unphased trial, this study offers an opportunity to explore new pain relief options for those seeking alternatives.

Will I have to stop taking my current medications?

You can continue taking your current pain medications as long as you don't change the dosage for at least 14 days before joining the study and during the study. However, you must avoid taking any pain medication for at least 6 hours before recording your foot pain level.

What prior data suggests that the Erchonia® EVRL™ device is safe for use in treating idiopathic neuropathy foot pain?

Research shows that the Erchonia® EVRL™ laser, which uses red and violet light, is generally well-tolerated, with few side effects. Previous studies have found that this type of low-level laser therapy is usually safe, with no major harmful effects reported. The FDA has approved the EVRL laser for other uses, indicating it meets certain safety standards when used correctly. This suggests it is safe for those seeking temporary relief from foot pain caused by idiopathic neuropathy, a condition where nerve damage causes pain without a known cause. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for peripheral neuropathy, which often rely on medications like pain relievers or antidepressants to manage symptoms, the Erchonia® EVRL™ laser therapy uses a unique combination of a 635-nanometer red laser and a 405-nanometer violet laser. This handheld device delivers targeted light therapy to potentially reduce nerve pain and promote healing at the cellular level. Researchers are excited about this approach because it offers a non-invasive, drug-free alternative with the potential for fewer side effects and quicker symptom relief.

What evidence suggests that the Erchonia® EVRL™ is effective for temporary relief of idiopathic neuropathy foot pain?

Research has shown that the Erchonia® EVRL™ laser device, used by participants in this trial, can help reduce foot pain. Earlier studies using low-level laser light, like the red and violet lasers in this device, lowered pain scores for most treated individuals. For instance, one study found that a single treatment reduced pain in 75% of participants. Another study showed that 80% of people using a similar laser experienced at least a 30% drop in their pain levels. These findings suggest that the Erchonia® EVRL™ could provide temporary relief for foot pain caused by idiopathic neuropathy, where nerve damage in the feet leads to pain. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 22 with idiopathic peripheral neuropathy diagnosed within the last 6 months. Participants must speak English, avoid other foot pain therapies during the study, not take pain meds 6 hours before assessments, have ongoing foot pain rated at least 50 on a scale to 100, and be on a stable pain medication regimen.

Inclusion Criteria

I can read and write in English.

I was diagnosed with idiopathic peripheral neuropathy by a doctor in the last 6 months.

I am over 22 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-administer the Erchonia® EVRL™ laser treatment at home for temporary relief of idiopathic peripheral neuropathy foot pain

6 weeks

Home-based treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Erchonia® EVRL™

Trial Overview The Erchonia® EVRL™ laser device is being tested for its effectiveness in providing temporary relief of foot pain caused by idiopathic peripheral neuropathy. The study involves using this device as prescribed at home under the guidance of health professionals.

How Is the Trial Designed?

Group I: Erchonia® EVRL™ Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Erchonia Corporation

Lead Sponsor

Trials

45

Recruited

2,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05091047?term=erchonia&rank=7

Effect of the Erchonia® EVRL OTC™ for the Relief ... This study is to see if applying red and violet low-level laser light can help to reduce foot pain associated with diabetic peripheral neuropathy,. Detailed ...

2. erchonia.com erchonia.com/products/evrl/

EVRL Laser - Red and Violet Therapy Laser By combining these two specific wavelengths into one treatment modality, patients received better results during clinical studies then the dual red and opened up ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6724421/

Effects of a single treatment with two nonthermal laser ... A single treatment resulted in diminished pain scores in 75% of subjects with increased ROM and overall subject satisfaction.

4. erchonia.com erchonia.com/wp-content/uploads/2022/10/Berry_Two-Randomized-Double-Blind-Placebo-Controlled-Trials-Evaluating-the-Efficacy-of-Red-635nm-3LT-for-the-Treatment-of-Low-.pdf

Two Randomized, Double Blind, Placebo- Controlled Trials ... At the end of the study, most subjects treated with the low-level laser (80%) achieved a ≥ 30% decrease in baseline LBP VAS scores vs.

5. erchonia-emea.com erchonia-emea.com/lllt/

Low-Level Laser Therapy Uses, Benefits, Side Effects ... The efficacy of Erchonia® lasers has been scientifically proven with double blind, randomised, placebo-controlled, and multi-site studies. Many ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K191257.pdf

K191257 Trade/Device Name: Erchonia - accessdata.fda.gov The Erchonia® EVRL (Model# EVRL) is a low-level laser system that uses two semi-conductor diodes (visible red and violet light), red: 630-650 nm ...

7. erchonia.com erchonia.com/wp-content/uploads/2021/06/EVRL-Datasheet_Rev-4-080217.pdf

EVRL Operating at a wavelength of 405nm and 635nm, the EVRL Laser provides the practitioner with an innovative tool for treatment versatility. The EVRL Laser System.