PDN post-market study

• Research type

  Research Study

• Full title

  Efficacy of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy

• IRAS ID

  314578

• Contact name

  Sarah Love-Jones

• Contact email

  sarah.love-jones@nbt.nhs.uk

• Sponsor organisation

  Nevro Corp

• Clinicaltrials.gov Identifier

  NCT05301816

• Duration of Study in the UK

  3 years, 11 months, 31 days

• Research summary

  The purpose of this post-market study is to evaluate the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (PDN). This is a multicenter, prospective, observational global study, that will partner diabetes management teams with pain physicians to provide an interdisciplinary treatment regimen for PDN patients. Outcomes will be assessed via standardized assessments.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  22/LO/0670

• Date of REC Opinion

  12 Oct 2022

• REC opinion

  Unfavourable Opinion