Back to resultsEffect of the Erchonia® EVRL OTC™ for the Relief of Diabetic Peripheral Neuropathy Foot Pain
Primary Purpose
Neuropathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erchonia EVRL
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathy
Eligibility Criteria
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
Sites / Locations
- Erchonia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Erchonia EVRL
Arm Description
635 nanometers (nm) and 405 nm laser application
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05091047
Brief Title
Effect of the Erchonia® EVRL OTC™ for the Relief of Diabetic Peripheral Neuropathy Foot Pain
Official Title
A Pilot Evaluation of the Effect of the Erchonia® EVRL OTC™ for the Relief of Diabetic Peripheral Neuropathy Foot Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erchonia Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erchonia EVRL
Arm Type
Experimental
Arm Description
635 nanometers (nm) and 405 nm laser application
Intervention Type
Device
Intervention Name(s)
Erchonia EVRL
Intervention Description
42 procedure administrations with the Erchonia® EVRL™ administered by the subject at home: Twice daily procedure administrations for 3 weeks.
Primary Outcome Measure Information:
Title
Change in Pain Numerical Rating Scale (NRS)
Description
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.
Time Frame
Baseline and 3 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Erchonia
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32904
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of the Erchonia® EVRL OTC™ for the Relief of Diabetic Peripheral Neuropathy Foot Pain
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