PDN post-market observational study
Research type
Research Study
Full title
A Post-Market, Multicenter, Prospective, Global Clinical Study to Evaluate the Real-World Experience of Spinal Cord Stimulation that Includes 10 kHz in the Management of Chronic Intractable Pain Associated with Diabetic Neuropathy.
IRAS ID
323090
Contact name
Sarah Love-Jones
Contact email
Sponsor organisation
Nevro Corp
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
The aim of this post-market study is to evaluate the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic leg pain due to painful diabetic neuropathy (PDN), who do not respond to pain medication. A recent randomised control trial (RCT) demonstrated the treatment efficacy Nevro's SCS system in patients with PDN. In this observational study the aim is to evaluate the benefits in a real-world health care setup.
REC name
West of Scotland REC 1
REC reference
23/WS/0021
Date of REC Opinion
28 Mar 2023
REC opinion
Further Information Favourable Opinion