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

NCT05091047 | Completed Results FDA Device

• 1 other identifier: R-DPN-OTC Pilot
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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,

Conditions

Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Erchonia EVRL

EXPERIMENTAL

635 nanometers (nm) and 405 nm laser application

Device: Erchonia EVRL

Interventions

Erchonia EVRL DEVICE

42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks.

Erchonia EVRL

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 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

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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Erchonia

Melbourne, Florida, 32904, United States

Location

Results Point of Contact

• Title: Clinical Affairs Manager
• Organization: Erchonia Corporation

tsammons@erchonia.com

888.242.0571

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: June 16, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 6, 2022
• Results First Posted: June 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)