Status:
RECRUITING
PDN Post Market, Multicenter, Prospective, Global Clinical Study
Lead Sponsor:
Nevro Corp
Conditions:
Diabetic Neuropathy, Painful
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 n...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
497 Patients enrolled
Trial Details
Trial ID
NCT05301816
Start Date
July 5 2022
End Date
October 1 2028
Last Update
November 7 2024
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Neuroversion, Inc.
Anchorage, Alaska, United States, 99508
2
Michigan Pain Specialists
Ann Arbor, Michigan, United States, 48108
3
Henry Ford Health
West Bloomfield, Michigan, United States, 48322
4
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210