Recruiting

Erchonia EVRL

Sponsor:

Erchonia Corporation

Code:

NCT06912646

Conditions

Neuropathy

Neuropathy;Peripheral

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Erchonia® EVRL™

Study Details

Brief 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.

Conditions

Neuropathy

Neuropathy;Peripheral

Study ID

NCT06912646

Start date

May 1, 2025

Status verified date

Sep, 2025

Completion date

Jun 16, 2027

Anticipated

Primary completion date

May 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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:

  • 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.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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. 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.

Primary outcome measure

  • Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale [ Time Frame: Baseline and 3 weeks ]

Central Contacts and Locations

Central contacts

Travis Sammons

8882420571tsammons@erchonia.com

Locations

Franco & Co

Recruiting

Miramar, Florida, United States, 33025

Contacts

Sandra Franco, DPM

sfranco@francoandcompany.com

More Information

Sponsor

Erchonia Corporation

Last update posted

Sep 8, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Erchonia Corporation on 2025-09-08.