Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain

Completed · Not applicable · Has a placebo group

Conditions studied: Neuropathy, Diabetic, Neuropathy;Peripheral, Neuropathy, Painful

In brief

The purpose of this clinical study is to determine the effectiveness of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Company), in providing prescription home use application for temporary relief of diabetic neuropathy foot pain in individuals diagnosed with diabetic neuropathy by a suitably qualified and licensed health professional.

Key facts

Study ID

NCT05291975

Run by

Erchonia Corporation

People needed

64

Starts

2022-02-17

Expected to finish

2024-12-12

Last updated by the study team

2025-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously diagnosed with diabetes induced peripheral neuropathy by a suitably qualified and licensed health professional within the past 6 months
• 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.
• If using analgesics (pain medication), you must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14 days prior to enrollment; and willing and able to not have planned upward dose titration of analgesics during the study period. You may elect to decrease analgesic use during the study. Cannabis prescribed for medicinal purposes would qualify as an analgesic in this context.
• 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.
• Agrees to refrain from taking a dosage of analgesic (pain medication) for at least 6 hours before a scheduled VAS foot pain rating is to be recorded.
• Subjects' degree of foot pain on the 0-100 VAS, with "0" being no pain and "100" being worst pain imaginable, is 50 or greater.

You may not qualify if…

• Pregnant or think you might be pregnant.
• Open wounds (sores, cuts, ulcers, etc) around the feet
• Cancerous growths around the feet
• Difficulty with hand dexterity sufficient to impact ability to administer treatments with the laser such as from severe arthritis in the hands, Multiple Sclerosis, Cerebral Palsy, Parkinson's Disease, Huntington's Disease, etc.

Where it is running

• CiC Foot & Ankle — Phoenix, Arizona, United States
• Laser Chiropractic — West Covina, California, United States
• Cesar A. Lara M.D. Weight Loss & Wellness — Dunedin, Florida, United States
• FRANCO & CO Podiatric Medicine & Surgery — Miramar, Florida, United States

Full record on ClinicalTrials.gov

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