NevroNevro this week announced it enrolled the first patient in its painful diabetic neuropathy (PDN) sensory study.

The prospective randomized controlled trial will assess the restoration of neurological function as a primary objective in patients with intractable PDN. It will enroll up to 236 patients at multiple sites across the U.S.

Patients in the trial will be randomized to conventional medical management or 10 kHz Therapy, along with conventional medical management with optional crossover to the other treatment arm at 6 months if the criteria are met.

The FDA previously granted breakthrough device designation for the study and the potential device indication. The FDA’s designation enables Nevro to receive a quicker review for its marketing application, which seeks to broaden its FDA labeling. This will give patients and healthcare providers faster access to vital medical devices that can provide improved treatment or diagnosis of serious, irreversible conditions.

“This PDN Sensory Study affords a path forward to building clinical evidence for slowing the progression of or improving sensory loss of the lower limbs in patients with chronic intractable pain and builds on the significant outcomes seen in the landmark SENZA-PDN RCT,” said Dr. Mitchel Engle, a physician at the Institute of Precision Pain Medicine in Corpus Christi, Texas. “It also offers a unique opportunity for patients with refractory painful diabetic neuropathy to participate in a research study utilizing 10 kHz SCS, a proven minimally invasive, completely reversible technology, with powered study endpoints targeting the disease-modifying benefits of improved neurological function and pain relief.”

The socioeconomic impact of diabetes and peripheral neuropathy is considerable and there is currently no available treatment that can modify the disease for patients with PDN, according to the company. In the U.S. alone, a diabetes-related amputation occurs every 20 seconds, as reported by the American Limb Preservation Society.

Patients who lack protective sensation in their feet due to numbness or insensate conditions are at risk of unnoticed injuries and foot ulcers. The treatment of foot ulcers and associated amputation surgeries can be costly, both financially and emotionally. By restoring sensation in the feet, 10 kHz Therapy has the potential to relieve this substantial disease burden, prevent amputations, and allow patients to be more active, which would improve their overall health and quality of life while reducing healthcare costs.

“The observed neurological improvements we saw in the SENZA-PDN study are unique to 10 kHz Therapy and have not been reported for any other competitive SCS modality,” said Kevin Thornal, CEO and President of Nevro. “Not only do we anticipate that this study will provide additional confirmatory evidence of the benefits of Nevro’s proprietary 10 kHz Therapy in these PDN patients, but we also believe that the additional Level 1 data generated will be very helpful as we continue to work with payers to expand PDN coverage generally and professional societies to update PDN clinical treatment guidelines.”