Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain

Neuropathy;Peripheral Clinical Trial

Official title: Clinical Efficacy and Human Factors Validation Testing for Prescription Home Use of the Erchonia Corporation EVRL™ for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain

Status Recruiting

Clinical Trial Summary

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 diabetic neuropathy foot pain in individuals diagnosed with diabetic neuropathy by a suitably qualified and licensed health professional.

Clinical Trial Description

Human Factors Validation Testing will initially be conducted to valuate a lay person's ability to understand and apply as applicable the information contained in the EVRL™ Use Device Proper Use Reference Guide, and device packaging and labeling materials to correctly, safely, and successfully activate and operate the EVRL™ to administer the treatment; and to identify any and all use difficulties, problems and errors, including those pertaining to critical tasks and close calls demonstrated by the lay person during device operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification, as applicable

Phase Two will commence following the successful completion of Phase One. Phase Two comprises the performance of a double-blind, randomized, placebo-controlled, clinical study of the efficacy of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Sponsor), for prescription home use application in providing temporary relief of diabetic peripheral neuropathy foot pain. ;

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuropathy, Diabetic
• Neuropathy, Painful
• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

• NCT number: NCT05291975
• Study type: Interventional
• Source: Erchonia Corporation
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2022
• Completion date: December 17, 2024