Phase
Condition
Neurologic Disorders
Neuropathy
Treatment
Erchonia® EVRL™
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Previously diagnosed with idiopathic peripheral neuropathy by a suitably qualifiedand 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 14days prior to study enrollment; and be willing and able to not have planned upwarddose titration of analgesics during the study period. Decreasing frequency ofanalgesic use during the study is permitted. Cannabis prescribed for medicinalpurposes qualifies as an analgesic in this context
Willing and able to refrain from engaging in any non-study therapies for themanagement of foot pain throughout the course of study participation, includingconventional therapies such as physical therapy, occupational therapy, hot or coldpacks, and alternative therapies such as chiropractic care and acupuncture
Agrees to refrain from taking a dosage of analgesic (pain medication) for at least 6hours 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
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 peripheralneuropathy 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 theintended 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 toadminister treatments with the laser such as from severe arthritis in the hands,Multiple Sclerosis, Cerebral Palsy, Parkinson's Disease, Huntington's Disease, etc.
Study Design
Study Description
Connect with a study center
Franco & Co
Miramar 4164601, Florida 4155751 33025
United StatesActive - Recruiting

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