PDN Post Market, Multicenter, Prospective, Global Clinical Study

Launched by NEVRO CORP · Mar 25, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well a treatment called Spinal Cord Stimulation (SCS) works for people with painful diabetic neuropathy (PDN), a condition that causes chronic leg pain in individuals with diabetes. The study will involve patients from multiple centers around the world and aims to gather real-life experiences of those using Nevro’s SCS therapy. Doctors who specialize in diabetes management will work alongside pain specialists to provide comprehensive care for participants. Researchers will use standardized assessments to measure the results.

To be eligible for the trial, participants must have a diabetes diagnosis and experience significant leg pain (rated at 5 out of 10 or higher on a pain scale) that has not improved with usual treatments. They should also be committed to following study procedures and attending scheduled visits. However, those with certain conditions, like specific types of nerve pain or serious leg issues, may not qualify. Participants can expect to receive SCS therapy and will be closely monitored throughout the study to evaluate the effectiveness of this treatment.

Gender

ALL

Eligibility criteria

• 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 scheduled visits.
• Exclusion Criteria:
• To participate in the study, patients must not meet any of the following exclusion criteria:
• • 1. 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
• • 2. 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.
• • 3. 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).