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

Not Applicable

Completed

• Conditions: Neuropathy
• Interventions: Device: Erchonia EVRL

• Registration Number: NCT05091047
• Lead Sponsor: Erchonia Corporation

Brief Summary

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,

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 Timeline

• Study Start: 2021-06-16
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-25
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Results First Submitted: 2022-02-16
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-10
• Last Update Submitted: 2022-05-10
• Results First Posted: 2022-06-06
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erchonia EVRL	Erchonia EVRL	635 nanometers (nm) and 405 nm laser application

Primary Outcome Measures

Name	Time	Method
Change in Pain Numerical Rating Scale (NRS)	Baseline and 3 week	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.

Trial Locations

Locations (1)

Erchonia; 🇺🇸 Melbourne, Florida, United States