Regenesis Biomedical, a Scottsdale-based medical device company, has initiated a multi-center, randomized clinical trial assessing the Provant® Therapy System for relieving symptoms of painful diabetic distal symmetric peripheral neuropathy (DSPN).
Painful neuropathy affects over 3 million people in the United States, resulting in nerve damage in the extremities such as tingling, numbness, pain and sensitivity to touch in your feet. The American Diabetes Association estimates the annual cost of DSPN to be $66 billion.
The Provant Therapy System is currently FDA-cleared for the treatment of postoperative pain and edema of soft tissue, and is used throughout the Veterans Affairs system as a safe, non-drug alternative to prescription opioids. Upon completion of this clinical trial, Regenesis Biomedical intends to secure FDA 510(k) clearance for the DSPN indication and apply for Medicare coverage and reimbursement.
The trial is titled A Multi-Center, Double-Blind, Sham-Controlled, Randomized Trial of Dual Field PEMF Therapy [Provant® Therapy System] in Lower Extremity Painful Diabetic Distal Symmetric Peripheral Neuropathy (DSPN) (the RELEIF Trial). 18 centers across the U.S. began enrolling subjects in late March. Total enrollment of 170 subjects and data analyses are expected to be completed in early 2019.
You may learn more about Regenesis Biomedical and Provant Therapy at www.regenesisbio.com