PDN Post Market, Multicenter, Prospective, Global Clinical Study (PDN-PM)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Neuropathy, Painful
• Intervention / Treatment: Device: Spinal Cord Stimulator (SCS)

• Study Type: Interventional
• Enrollment (Estimated): 497
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manish Bharara, PhD; Phone Number: 1 (650) 785 1061; Email: manish.bharara@nevro.com
• Study Contact Backup: Name: Kerry Bradley; Phone Number: 1-650-251-0005; Email: bradley@nevro.com

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Active, not recruiting
      • Neuroversion, Inc.
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • Recruiting
      • Michigan Pain Specialists
      • Principal Investigator: Edward Washabaugh, MD
      • Contact: Cathy Baker; Phone Number: 734-373-7246
    • West Bloomfield, Michigan, United States, 48322
      • Recruiting
      • Henry Ford Health
      • Contact: Rehnuma Newaz; Phone Number: 248-325-2064; Email: rnewaz1@hfhs.org
      • Principal Investigator: Ellen Air, MD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Wexner Medical Center
      • Contact: Alberto Uribe, MD; Phone Number: 614-293-0775
      • Principal Investigator: Tristan Weaver, MD
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Active, not recruiting
      • Clinical Investigations, LLC
  • Oregon
    • Milwaukie, Oregon, United States, 97222
      • Recruiting
      • Columbia Pain Management
      • Contact: Cherie Flory, RN; Phone Number: 219 541-386-9500
      • Principal Investigator: David Russo, MD
      • Sub-Investigator: Vishal Khemlani, MD
  • Pennsylvania
    • York, Pennsylvania, United States, 17402
      • Recruiting
      • WellSpan Interventional Pain Specialists
      • Principal Investigator: Rajat Mathur, MD
      • Contact: Vikas Bansal, MBBS, MPH
  • Virginia
    • Roanoke, Virginia, United States, 24018
      • Recruiting
      • Virginia Interventional Pain & Spine Centers
      • Contact: Jessica Pickel; Phone Number: 540-777-0090
      • Principal Investigator: Chheany W.C. Ung, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: IPG Activated; The group of participants who have had a successful trial (>50% pain relief) during the trial phase

Device: Spinal Cord Stimulator (SCS); Spinal cord stimulation system (SCS) is an approved system to manage chronic intractable pain of the limbs and/or leg by delivering electrical stimulation using implantable leads and rechargeable implantable pulse generator (IPG) with 16 output channels. The IPG is implanted in a subcutaneous pocket and is capable of stimulating the spinal cord nerves when used with one or two 8-contact percutaneous or paddle leads.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial success rate/Responder rate	Percentage of patients with a successful trial phase (responder rate) i.e. at least 50% reduction in patient-reported overall pain relief.	2 weeks
Patient-reported overall pain relief	The average percentage of patient-reported pain relief at 3,6 and 12 months.	12 months
Leg pain	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	12 months
Quality of life measure	Change from baseline in quality of life at 3, 6 and 12 months will be assessed using the EQ-5D-5L questionnaire.	12 months
Pain Inventory	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.	12 months
Global impression of change in health status	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".	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients Work Status	Patients' current work status (working for pay, working without pay, self-employed, out of work for more than 1 year, out of work for less than 1 year, homemaker/taking care of the house and/or family, student, retired, unable to work) will be collected at baseline and repeated at the 12 months follow up visit.	12 months
Device Safety	Subjects will be assessed for the procedure and device-related adverse events starting at enrollment and continuing through study completion. An adverse event may include but is not limited to infection, lead revisions, IPG revisions, device malfunction, and explantation of devices.	12 months

Collaborators and Investigators

• Sponsor: Nevro Corp
• Investigators: Study Director: David Caraway, MD, Chief Medical Officer, Nevro Corp

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Spinal Cord Stimulation (SCS)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetes Complications; Diabetic Neuropathies
• Other Study ID Numbers: CA2021-03 INT PDN-PM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes