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Erchonia EVRL for Idiopathic Peripheral Neuropathy Foot Pain

This study is looking at how well a device called the Erchonia® EVRL™ helps with foot pain caused by idiopathic peripheral neuropathy (nerve damage with no known cause). The Erchonia® EVRL™ uses red and violet laser light. You might be able to join if you are over 22, have been diagnosed with this type of neuropathy in the last 6 months, have had constant foot pain for at least 3 months, and can read and write English. If you take pain medication, it needs to be a stable dose. The main goal is to see how many participants have at least a 30% improvement in their pain after 3 weeks. The study is currently unclear on its recruitment status.

Study design
This is a single-arm study, meaning all 32 participants will receive the active Erchonia® EVRL™ treatment. There is no specified phase for this interventional study.
What's involved
Participants will self-administer treatments with the Erchonia® EVRL™ device at home. Pain levels will be measured at the start of the study and again after 3 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants' pain levels will be assessed at 3 weeks after starting the study.

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NCT06912646

Clinical Efficacy of the Erchonia EVRL for Providing Temporary Relief of Idiopathic Peripheral Neuropathy Foot Pain

Recruiting
NAAges 22+InterventionalTreatment
Erchonia Corporation
~32 participants
Updated 2025-09-08 on ClinicalTrials.gov
What's tested:Erchonia® EVRL™

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale
Measured over Baseline and 3 weeks

Conditions

Neuropathy
Neuropathy;Peripheral

Explore related trials

Peripheral Neuropathy

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Travis Sammons
[email protected]
8882420571
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Previously diagnosed with idiopathic peripheral neuropathy by a suitably qualified and licensed health professional within the past 6 months.
Over the age of 22 years of age
Able to read and write English
Constant feet pain on-going over at least the past 3 months
Subjects 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 study enrollment; and be willing and able to not have planned upward dose titration of analgesics during the study period. Decreasing frequency of analgesic use during the study is permitted. Cannabis prescribed for medicinal purposes qualifies as an analgesic in this context
Willing and able to refrain from engaging in any non-study therapies for the management of foot pain throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy, hot or cold packs, and 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
Subject's 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

Diabetic, referred to as having hemoglobin A1c (HbA1C) of 6.5% or higher
Previously diagnosed with any definitive (i.e. not idiopathic) cause of peripheral neuropathy by a suitably qualified and licensed health professional within the past 6 months, such as diabetes, injury, infection, toxins and poisons, alcoholism, medications such as chemotherapy, autoimmune disorders, etc..
Pregnant or possibly pregnant, breastfeeding, or planning pregnancy during the intended course of study participation
Open wounds (sores, cuts, ulcers, etc.) on or around the treatment area on the feet
Cancerous growths or lesions on or around the treatment area on the feet
Difficulty with hand dexterity sufficient to negatively impact the 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.

What this trial measures

  • Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog ScaleBaseline and 3 weeks

    The Visual Analog Scale (VAS) will be used to assess pain from baseline to the 6-week endpoint for each subject. Subjects will be instructed to indicate the overall level of pain experienced in their feet by placing a cross (X) on a 10-centimeter horizontal line. The left end of the line will be labeled "0," representing "no pain," and the right end will be labeled "100," representing "the worst pain imaginable." 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 VAS pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome.