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

NCT05291975 | Completed Results FDA Device

• 1 other identifier: R-DPN-HOME
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Neuropathy, Diabetic; Neuropathy;Peripheral; Neuropathy, Painful

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)

  The Visual Analog Scale (VAS) from baseline to endpoint (6 weeks) measurement is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome. For the primary study outcome, the overall study success is defined as a 35% or greater difference between the proportion (number) of individual successes in each treatment group.

  Baseline and 3 weeks

Secondary Outcomes (2)

• Satisfaction With Study Outcome

  Baseline and 3 weeks

• Four Weeks Post Procedure Change in Foot Pain Visual Analog Scale (VAS) Score

  Baseline and 7 Weeks

Study Arms (2)

Erchonia® EVRL™

ACTIVE COMPARATOR

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.

Device: Erchonia® EVRL™

Placebo Laser

PLACEBO COMPARATOR

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

Device: Placebo Laser

Interventions

Erchonia® EVRL™ DEVICE

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.

Erchonia® EVRL™

Placebo Laser DEVICE

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.

Placebo Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously diagnosed with diabetes induced peripheral neuropathy by a suitably qualified and licensed health professional within the past 6 months
• 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.
• If using analgesics (pain medication), you must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14 days prior to enrollment; and willing and able to not have planned upward dose titration of analgesics during the study period. You may elect to decrease analgesic use during the study. Cannabis prescribed for medicinal purposes would qualify as an analgesic in this context.
• 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.
• Agrees to refrain from taking a dosage of analgesic (pain medication) for at least 6 hours before a scheduled VAS foot pain rating is to be recorded.
• Subjects' degree of foot pain on the 0-100 VAS, with "0" being no pain and "100" being worst pain imaginable, is 50 or greater.

You may not qualify if:

• Pregnant or think you might be pregnant.
• Open wounds (sores, cuts, ulcers, etc) around the feet
• Cancerous growths around the feet
• Difficulty with hand dexterity sufficient to impact ability to administer treatments with the laser such as from severe arthritis in the hands, Multiple Sclerosis, Cerebral Palsy, Parkinson's Disease, Huntington's Disease, etc.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (4)

CiC Foot & Ankle

Phoenix, Arizona, 85028, United States

Location

Laser Chiropractic

West Covina, California, 91790, United States

Location

Cesar A. Lara M.D. Weight Loss & Wellness

Dunedin, Florida, 34698, United States

Location

FRANCO & CO Podiatric Medicine & Surgery

Miramar, Florida, 33025, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Neuritis; Neuropathy, Painful

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Affairs Manager
• Organization: Erchonia Corporation

tsammons@erchonia.com

8882420571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: February 17, 2022
• Primary Completion: October 16, 2024
• Study Completion: December 12, 2024
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)