NCT05291975

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

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Erchonia Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neuropathy, Diabetic
• Neuropathy;Peripheral
• Neuropathy, Painful

Interventions

Type	Name	Description
DEVICE	Erchonia® EVRL™	The 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.
DEVICE	Placebo Laser	The Placebo Laser has the same appearance as the Erchonia® EVRL™ but does not emit any therapeutic light. 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.

Timeline

• Start date: 2022-02-17
• Primary completion: 2024-10-16
• Completion: 2024-12-12
• First posted: 2022-03-23
• Last updated: 2025-08-13
• Results posted: 2025-08-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study