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

NCT ID: NCT06912646

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-06-16

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.

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.

Conditions

Neuropathy; Neuropathy;Peripheral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Erchonia® EVRL™

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erchonia Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Franco & Co

Miramar, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Travis Sammons

Role: CONTACT

tsammons@erchonia.com

8882420571

Facility Contacts

Sandra Franco, DPM

Role: primary

sfranco@francoandcompany.com

Other Identifiers

R-IPN

Identifier Type: -

Identifier Source: org_study_id