PDN Post Market, Multicenter, Prospective, Global Clinical Study
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 t
| Condition(s) | Diabetic Neuropathy, Painful |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: To participate in the study, patients must meet all the following inclusion criteria: 1. 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. 2. 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. 3. 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. 4. Be willing and capable of giving written informed consent. 5. Be willing and able to comply with study-related requirements and procedures and attend all schedu |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Nevro Corp |
| Locations | Anchorage, Alaska, United States; Ann Arbor, Michigan, United States; West Bloomfield, Michigan, United States; Columbus, Ohio, United States; Edmond, Oklahoma, United States; Milwaukie, Oregon, United States (+2 more sites) |
| Start date | 2022-07-05 |
| NCT ID | NCT05301816 |
| Official listing | https://clinicaltrials.gov/study/NCT05301816 |