Actively Recruiting
Evaluation of the Erchonia4 EVRL12 Device for Temporary Relief of Idiopathic Peripheral Neuropathy Foot Pain Using Prescription Home Use
Led by Erchonia Corporation · Updated on 2025-09-08
32
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of the Erchonia4 EVRL12 for home use to temporarily relieve foot pain caused by idiopathic peripheral neuropathy. This condition causes persistent foot pain without a known cause, and participants must have been diagnosed by a qualified health professional. The study focuses on individuals dealing with ongoing foot pain and aims to understand how well this laser device can reduce pain levels over time. The study involves a single group of participants who will all use the active Erchonia4 EVRL12 device at home. This portable handheld device contains two laser diodes, one red (635 nanometers) and one violet (405 nanometers), which are applied approximately 3 to 6 inches above the top of each foot. Participants will self-administer treatments twice daily for 21 days, with each session lasting 5 minutes per foot, totaling 10 minutes per day. During the study, participants will track their pain levels using the Visual Analog Scale and the Neuropathic Pain Symptom Inventory at the start and after 3 weeks. Researchers will monitor changes in pain ratings to measure the device's effect. Participants must follow specific guidelines, including stable pain medication use and avoiding other foot pain therapies during the study. The total participation time spans at least three weeks of treatment and assessment.
CONDITIONS
Brief Title
Clinical Efficacy of the Erchonia EVRL for Providing Temporary Relief of Idiopathic Peripheral Neuropathy Foot Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously diagnosed with idiopathic peripheral neuropathy by a licensed health professional within the past 6 months
- Age 22 years or older
- Able to read and write English
- Experiencing constant foot pain for at least the past 3 months
- Using stable analgesic medication regimen for at least 14 days before enrollment with no planned dose increases during the study
- Willing and able to avoid other foot pain therapies during the study
- Able to refrain from taking analgesics at least 6 hours before pain rating assessments
- Foot pain rating of 50 or greater on a 0-100 Visual Analog Scale
You will not qualify if you...
- Diagnosis of diabetes with hemoglobin A1c of 6.5% or higher
- Diagnosed with a known cause of peripheral neuropathy other than idiopathic within the past 6 months
- Pregnant, breastfeeding, or planning pregnancy during the study
- Open wounds or cancerous growths on or around the feet
- Difficulty with hand dexterity that would affect ability to use the laser device due to conditions like severe arthritis, Multiple Sclerosis, Cerebral Palsy, Parkinson's Disease, or Huntington's Disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 21 days
Participants self-administer the Erchonia® EVRL™ laser treatment at home twice daily to provide temporary relief of foot pain due to idiopathic peripheral neuropathy.
Twice daily self-administered treatments at home
Trial Site Locations
Total: 1 location
1
Franco & Co
Miramar, Florida, United States, 33025
Actively Recruiting
Research Team
T
Travis Sammons
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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