N/A
N=8
Effect of the Erchonia® EVRL OTC™ for the Relief of Diabetic Peripheral Neuropathy Foot Pain
Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT05091047 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Change in Pain Numerical Rating Scale (NRS) — 43.75 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Erchonia EVRL (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Erchonia Corporation
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Numerical Rating Scale (NRS) |
43.75 | — |
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,
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
Data sourced from ClinicalTrials.gov (NCT05091047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.