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™ — DEVICEThe 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
- Travis Sammons8882420571
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Franco & Co | Miramar | Florida | 33025 | Sandra Franco, DPM |
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