ClinicalTrials.gg
RecruitingNCT06912646Updated Sep 8, 2025

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

An interventional study of Erchonia® EVRL™ in Neuropathy and Neuropathy;Peripheral, sponsored by Erchonia Corporation. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Erchonia Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 27 studies in Neuritis with a site in United States — 5 open to participants now, 7 under way, 1 of them phase 3. Neuritis · United States.

Planned enrollment
10th of 23
32 · median 30
Started
2025
the only one that year
No phase
12 of 27
2 open now
Registered
25th of 27
by date
Lead sponsor
2 of 27
Erchonia Corporation

Among the 27 studies in Neuritis with a site in United States, this one is the 10th largest by planned enrollment of the 23 interventional ones that give a count, is the only one that started in 2025, is one of 12 with no phase, and was the 25th registered.

Neuritis

73 studies on the registry are indexed under Neuritis; 20 are open to participants now.

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Open to participants now

5 of the 27 studies in Neuritis with a site in United States are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 14 Neuritis studies recruiting now, 11 (79%) set no upper age limit and 1 (7%) stops at 75 or younger; 2 take children under 18; 3 take healthy volunteers.

This study: 22 Years and older · all sexes · no healthy volunteers.

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02

Study 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 idiopathic neuropathy foot pain in individuals diagnosed with idiopathic neuropathy by a suitably qualified and licensed health professional.

Read the detailed description

This clinical study is a single-arm, active treatment group only, non-inferiority prospective design to evaluate the efficacy of the Erchonia® EVRL™ for prescription home use application in providing temporary relief of foot pain due to idiopathic peripheral neuropathy. There will be a single active treatment only subject group in this study. All enrolled subjects will self-administer the treatments with the active (true) Erchonia® EVRL™ laser in his or her own home.

03

Conditions studied

  • Neuropathy
  • Neuropathy;Peripheral

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04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • Diabetic, referred to as having (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, 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    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.

    Device: Erchonia® EVRL™

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.

06

What researchers measure

Primary outcomes

  1. Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale

    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.

    Time frame: Baseline and 3 weeks

Secondary outcomes

  1. Neuropathic Pain Symptom Inventory

    The Neuropathic Pain Symptom Inventory (NPSI) is a 12-item self-administered patient-reported outcome 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 a maximum total score of 100, a lower score from baseline to study endpoint represents a better outcome.

    Time frame: Baseline and 3 weeks

07

Study locations

1 of 1 sites recruiting
  • Franco & Co
    Miramar, Florida 33025, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for May 2027, 24 months after the start.

Of 23 interventional studies with no phase under Neuritis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 31. This study's planned 24 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2025
First posted
Apr 6, 2025
StartActual
May 1, 2025
Primary completionEst.
May 16, 2027
CompletionEst.
Jun 16, 2027
Last update
Sep 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06912646
Responsible party
Sponsor
First posted
Apr 6, 2025
Start date
May 1, 2025
Primary completion
May 16, 2027 (estimated)
Completion
Jun 16, 2027 (estimated)
Last update
Sep 8, 2025

Study contacts

Travis Sammons
Contact
tsammons@erchonia.com
8882420571

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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