A double-blind, placebo-controlled randomized evaluation of the effect of the Erchonia® FX-635™ on diabetic peripheral neuropathy pain clinical study protocol
PURPOSE OF THE STUDY
In this study, the Sponsor, Erchonia Corporation, and investigators are studying the use of a device called the Erchonia® FX-635™ that gives off low level laser light. This study is to see if using the Erchonia® FX-635 TM can help to reduce foot pain in people with diabetic peripheral neuropathy. The Erchonia® FX-635™ is cleared for marketing by the U.S. Food and Drug Administration (FDA) as an adjunct to reducing chronic heel pain arising from plantar fasciitis and as an adjunct to provide relief of minor chronic low back pain of musculoskeletal origin. However; its use in this study is investigational, as the FX-635™ has not been cleared for market by the FDA for reducing foot pain in individuals with diabetic peripheral neuropathy.
PROCEDURES
This study involves twelve laser light procedure with the Erchonia FX635 laser over 6 weeks. To take part in this study, you must agree to not take any medicines or try any other treatments to help with your foot pain, until your part in the study is over. You may take over-the-counter Tylenol according to the directions for use on the labeling to help with your foot pain while in the study, if you need to.
COSTS
It will not cost you anything to be part of the study. Erchonia Corporation, the sponsor of this research, will provide the treatments with the Erchonia FX-635™ free of charge during this study. The cost for all study related procedures and measurements will also be covered by Erchonia Corporation. Nothing will be billed to you or to your insurance company.
PAYMENT FOR PARTICIPATION
You will not be paid for your part in this research study.
QUESTIONS OR INTERESTED
If you have questions or interested in participating in the study, you may contact your closest research site:
Dr. Sandra Franco, DPM
Franco & Co Podiatry MedSpa
2407 Main Street
Miramar, FL 33025
(954) 436-7400
Dr. Jordan Steinberg, DPM
Florham Park Podiatry
83 Hanover Rd. #250
Florham Park, NJ 07932
(973) 922-0464
Dr. Jeffery Kleis, DPM
1503 S Coast Drive #317
Costa Mesa, CA 92626
(866) 333-8710
