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

Erchonia

Status

Completed

Conditions

Neuropathy

Treatments

Device: Erchonia EVRL

Study type

Interventional

Funder types

Industry

Identifiers

NCT05091047

R-DPN-OTC Pilot

Details and patient eligibility

About

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,

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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