NCT06912646

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

An Evaluation of the Effect of the Erchonia® EVRL™ for Prescription Home Use Application in Providing Temporary Relief From Idiopathic Peripheral Neuropathy Foot Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Erchonia Corporation · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-05-16
• Completion: 2027-06-16
• First posted: 2025-04-06
• Last updated: 2025-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study