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Completed

NCT Number: NCT05091047

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

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,

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erchonia

Melbourne, Florida, 32904, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erchonia EVRL

Device

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

Primary outcomes

  1. Change in Pain Numerical Rating Scale (NRS)

    Time frame: Baseline and 3 week

    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.

Sponsors and collaborators

Lead sponsor

Erchonia Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 25, 2021
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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