PDN Post Market, Multicenter, Prospective, Global Clinical Study

Running, not enrolling · Not applicable

Conditions studied: Diabetic Neuropathy, Painful

In brief

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.

Key facts

Study ID

NCT05301816

Run by

Nevro Corp

People needed

497

Starts

2022-07-05

Expected to finish

2028-10-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To participate in the study, patients must meet all the following inclusion criteria:
• Have been clinically diagnosed with diabetes, according to the local country diabetes association guidelines, as well as painful diabetic neuropathy (PDN) of the lower limbs refractory to conventional medical management.
• Average pain intensity (over the last 7 days) of ≥5 out of 10 cm on the Visual Analog Scale (VAS) in the lower limbs at enrollment/baseline.
• The clinical decision has been made to provide treatment using the Nevro Spinal Cord Stimulation that includes 10 kHz therapy prior to enrollment in the study.
• Be willing and capable of giving written informed consent.
• Be willing and able to comply with study-related requirements and procedures and attend all scheduled visits.

You may not qualify if…

• To participate in the study, patients must not meet any of the following exclusion criteria:
• Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial or peroneal neuropathies), have had a lower limb amputation other than toes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs
• Have a medical condition or diagnosis that is inconsistent with Nevro's SCS System guidelines in the Physician's Manual for the relevant country, or as per standard clinical practice.
• Have a medical condition or pain in other areas, not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound the evaluation of study endpoints, as determined by the Investigator (such as primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis, peripheral vascular disease, or small vessel disease).

Where it is running

• Neuroversion, Inc. — Anchorage, Alaska, United States
• Michigan Pain Specialists — Ann Arbor, Michigan, United States
• Henry Ford Health — West Bloomfield, Michigan, United States
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Clinical Investigations, LLC — Edmond, Oklahoma, United States
• Columbia Pain Management — Milwaukie, Oregon, United States
• WellSpan Interventional Pain Specialists — York, Pennsylvania, United States
• Virginia Interventional Pain & Spine Centers — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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