Evaluating Spinal Cord Stimulation for Painful Diabetic Neuropathy

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.

This study is testing if spinal cord stimulation can help people with painful diabetic neuropathy feel less leg pain and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 497 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nevro Corp (Industry-sponsored)
• Locations: 8 sites (Anchorage, Alaska and 7 other locations)
• Trial ID: NCT05301816 on ClinicalTrials.gov

What this trial studies

This global clinical study aims to assess the real-world effectiveness of Nevro's Spinal Cord Stimulation (SCS) therapy in patients suffering from chronic leg pain due to painful diabetic neuropathy (PDN). It is a multicenter, prospective, observational study that collaborates diabetes management teams with pain specialists to create an interdisciplinary treatment approach. Patients will be evaluated using standardized assessments to measure outcomes related to their pain and overall quality of life.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with diabetes and painful diabetic neuropathy who have not found relief from conventional treatments.

Not a fit: Patients with lower limb mononeuropathy or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide significant pain relief and improved quality of life for patients with painful diabetic neuropathy.

How similar studies have performed: Previous studies on spinal cord stimulation for neuropathic pain have shown promising results, indicating potential success for this approach.

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).

Where this trial is running

Anchorage, Alaska and 7 other locations

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

Study contacts

• Study coordinator: Kerry Bradley

Conditions Diabetic Neuropathy, Painful; Spinal Cord Stimulation