Multiple sites across the US will be used to enrol up to 236 patients in the study.
Medical device company Nevro has recruited the first patient for the Painful Diabetic Neuropathy (PDN) Sensory Study.
The objective of the randomised controlled trial is to assess the restoration of neurological function in patients with intractable PDN.
Nevro CEO and president Kevin Thornal said: “The observed neurological improvements we saw in the SENZA-PDN study are unique to 10kHz Therapy and have not been reported for any other competitive SCS modality.
“Not only do we anticipate that this study will provide additional confirmatory evidence of the benefits of Nevro’s proprietary 10kHz 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.”
The study will involve 236 patients at multiple centres across the US. These patients will be randomly assigned to either conventional medical management or 10kHz Therapy in combination with conventional medical management.
If the criteria are met, there is an option for crossover to the other treatment arm after six months.
The PDN Sensory Study has been awarded breakthrough device designation by the US Food and Drug Administration (FDA), along with this potential device indication.
In October last year, Nevro secured approval from the FDA for its Senza HFX iQ spinal cord stimulation (SCS) system for the treatment of chronic pain.
It is developed to address the variability in pain from patient to patient and to optimise and maintain long-term pain relief, as well as improved life quality.