Effect of the Erchonia® EVRL OTC™ for the Relief of Diabetic Peripheral Neuropathy Foot Pain

A Pilot Evaluation of the Effect of the Erchonia® EVRL OTC™ for the Relief of Diabetic Peripheral Neuropathy Foot Pain

This study is to see if applying red and violet low-level laser light can help to reduce foot pain associated with diabetic peripheral neuropathy,

Study Overview

• Status: Completed
• Conditions: Neuropathy
• Intervention / Treatment: Device: Erchonia EVRL

Detailed Description

The purpose of this study is to determine whether low level laser therapy is effective in the reduction of foot pain associated with diabetic peripheral neuropathy, when used at home by non-medical professionals.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Melbourne, Florida, United States, 32904
      • Erchonia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Previously diagnosed with diabetes-induced Peripheral Neuropathy by a qualified health Physician.
• Over the age of 18 years of age
• Able to read and write English.
• Constant feet pain on-going over at least the past 3 months.
• Subject is willing and able to refrain from consuming any OTC and/or prescription medications including muscle relaxants and/or herbal supplements and/or recreational and medical drugs including cannabis intended for the relief of pain and/or inflammation throughout the course of study participation, except for the study-specific pain relief medication of OTC Tylenol.
• Subject is willing and able to refrain from engaging in any non-study procedure therapies for the management of foot pain throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture.
• Self-reported foot pain on the Numerical Rating Scale (NRS) is 50 or greater

Exclusion Criteria:

• Pregnant or think you might be pregnant.
• Open wounds (sores, cuts, ulcers, etc) around the feet
• Cancerous growths around the feet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erchonia EVRL; 635 nanometers (nm) and 405 nm laser application	Device: Erchonia EVRL; 42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Numerical Rating Scale (NRS)	The Numerical Rating Scale (NRS) assesses the level or degree of pain. With '0: no pain at all' and '100: worst pain imaginable. The subject will be asked to rate the level of foot pain he or she is experiencing at that time.	Baseline and 3 week

Collaborators and Investigators

• Sponsor: Erchonia Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: R-DPN-OTC Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No