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

Launched by ERCHONIA CORPORATION · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of a device called the Erchonia® EVRL™ in providing temporary relief for foot pain caused by idiopathic peripheral neuropathy, a condition that causes nerve pain without a known cause. The study aims to see if this device can help people who have been diagnosed with this type of neuropathy by a qualified healthcare professional within the past six months and have been experiencing constant foot pain for at least three months.

To be eligible for the study, participants need to be over 22 years old, able to read and write in English, and have a pain level of 50 or higher on a scale from 0 (no pain) to 100 (worst pain imaginable). Participants will need to avoid other treatments for foot pain during the study and will not be able to take pain medication for six hours before their pain is assessed. It's important to note that this study is not yet recruiting participants, so interested individuals will need to wait until the recruitment starts.

Gender

ALL

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.