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

Launched by ERCHONIA CORPORATION · Mar 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the Erchonia® EVRL™ device, which is designed to provide temporary relief from foot pain caused by diabetic neuropathy. Diabetic neuropathy is a condition that affects the nerves in people with diabetes, often leading to pain and discomfort in the feet. The goal of the study is to see how effective this device is for people who have been diagnosed with this condition by a healthcare professional.

To participate in the trial, individuals must be at least 18 years old and have been diagnosed with diabetic peripheral neuropathy in the last six months. Participants should be experiencing ongoing foot pain for at least three months and must be able to communicate in English. It's important to note that those with open wounds or severe hand dexterity issues are not eligible. Throughout the study, participants will use the device at home and will need to avoid other pain relief therapies. If you meet these criteria and are interested, this trial may offer a chance to help manage your foot pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.