PDN Post Market, Multicenter, Prospective, Global Clinical Study

Not Applicable

Recruiting

• Conditions: Diabetic Neuropathy, Painful
• Interventions: Device: Spinal Cord Stimulator (SCS)

• Registration Number: NCT05301816
• Lead Sponsor: Nevro Corp

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-03-31
• Study Start: 2022-07-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2027-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 497

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPG Activated	Spinal Cord Stimulator (SCS)	The group of participants who have had a successful trial (\>50% pain relief) during the trial phase

Primary Outcome Measures

Name	Time	Method
Patient-reported overall pain relief	12 months	The average percentage of patient-reported pain relief at 3,6 and 12 months.
Leg pain	12 months	Leg pain will be assessed using a 10 cm Visual Analog Scale (VAS) with 0 indicating no pain and 10 indicating the worst pain. Following outcome measures will be derived from the VAS score on leg pain.; * Responder rate for leg pain i.e. percentage of patients who experience at least 50% reduction in leg pain compared to Baseline at 3, 6, and 12 months.; * Change from Baseline in mean leg pain at 3, 6, and 12 months; * Percentage change from Baseline in mean leg pain at 3, 6, and 12 months
Pain Inventory	12 months	Change from baseline in pain symptoms at 3, 6 and 12 months assessed by 11-point BPI-DPN (Brief Pain Inventory for Diabetic Peripheral Neuropathy) pain scale, with 0 indicating no pain and 10 indicating worst pain.
Trial success rate/Responder rate	2 weeks	Percentage of patients with a successful trial phase (responder rate) i.e. at least 50% reduction in patient-reported overall pain relief.
Quality of life measure	12 months	Change from baseline in quality of life at 3, 6 and 12 months will be assessed using the EQ-5D-5L questionnaire.
Global impression of change in health status	12 months	The patient's general health status at 3, 6 and 12 months will be assessed both by the patients themselves as well as the study investigators using the 7-point PGIC (Patient Global Impression of Change) and the CGIC (Clinician Global Impression of Change) instrument respectively. Responses for this questionnaire range from "no change (or condition has got worse)" to "a great deal better".

Trial Locations

Locations (8)

WellSpan Interventional Pain Specialists; 🇺🇸 York, Pennsylvania, United States

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

Virginia Interventional Pain & Spine Centers; 🇺🇸 Roanoke, Virginia, United States