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

Part of paid clinical trials in Miramar, Florida.

Sponsor
Erchonia Corporation
Study ID
NCT06912646
Status
Recruiting

Conditions

  • Neuropathy
  • Neuropathy;Peripheral

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erchonia® EVRL™ — 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.

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Sep 2025
Primary completion
May 16, 2027
Completion
Jun 16, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Franco & CoMiramarFlorida33025
Sandra Franco, DPM

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