Home-use Erchonia EVRL laser for 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

This study will test whether a home-use Erchonia EVRL laser can provide temporary relief of foot pain for adults with idiopathic peripheral neuropathy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Erchonia Corporation (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Miramar, Florida)
• Trial ID: NCT06912646 on ClinicalTrials.gov

What this trial studies

This is a single-arm, prospective, active-treatment study in which all enrolled participants will self-administer the Erchonia EVRL device at home. The protocol targets adults over age 22 with a recent diagnosis of idiopathic peripheral neuropathy and at least three months of constant foot pain. Participants must be on a stable analgesic regimen and agree to avoid other non-study foot pain therapies during the study. Outcomes will measure temporary pain relief following prescribed home use of the active device.

Who should consider this trial

Good fit: Ideal candidates are adults (over 22) diagnosed with idiopathic peripheral neuropathy within the past six months who have had constant foot pain for at least three months, are on a stable pain medication regimen, and can self-administer the device and avoid other foot-pain therapies during the study.

Not a fit: Patients with secondary (non-idiopathic) neuropathy, those unwilling or unable to self-administer the device or to avoid other therapies, or those with unstable or recently changed analgesic regimens may not receive benefit from this protocol.

Why it matters

Potential benefit: If successful, the device could provide patients with a noninvasive, at-home option for short-term reduction of neuropathic foot pain.

How similar studies have performed: Some small trials of low-level laser therapy have reported modest short-term pain relief for peripheral neuropathy, but overall evidence is limited and mixed and home-use application of the Erchonia EVRL remains relatively novel.

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.

Where this trial is running

Miramar, Florida

• Franco & Co — Miramar, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: Travis Sammons

Conditions: Neuropathy, Peripheral