Clinical Efficacy of the Erchonia EVRL for Providing Temporary Relief of Idiopathic Peripheral Neuropathy Foot Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorErchonia Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Erchonia® EVRL™Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale
The Visual Analog Scale (VAS) will be used to assess pain from baseline to the 6-week endpoint for each subject. Subjects will be instructed to indicate the overall level of pain experienced in their feet by placing a cross (X) on a 10-centimeter horizontal line. The left end of the line will be labeled "0," representing "no pain," and the right end will be labeled "100," representing "the worst pain imaginable." Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A lower VAS pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome.
Time frame
Baseline and 3 weeksSecondary outcomes
1
Neuropathic Pain Symptom Inventory
The Neuropathic Pain Symptom Inventory (NPSI) is a 12-item self-administered patient-reported outcome assessment tool with a recall/ observation period of over the past 24 hours. It contains 10 descriptors representing 5 distinct dimensions on the basis of factor analysis: burning pain, deep pain, paroxysmal pain, evoked pain, paresthesia/dysesthesia, and 2 temporal items designed to assess pain duration and the number of pain paroxysms. The NPSI has a maximum total score of 100, a lower score from baseline to study endpoint represents a better outcome.
Time frame
Baseline and 3 weeksSponsors and contacts
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Source ClinicalTrials.gov