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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neuropathy

Intervention / Treatment
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* Device: Erchonia EVRL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |