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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05301816
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : January 17, 2024
Sponsor:
Information provided by (Responsible Party):
Nevro Corp

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy, Painful Device: Spinal Cord Stimulator (SCS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 497 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : July 5, 2022
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Trial success rate/Responder rate [ Time Frame: 2 weeks ]
    Percentage of patients with a successful trial phase (responder rate) i.e. at least 50% reduction in patient-reported overall pain relief.

  2. Patient-reported overall pain relief [ Time Frame: 12 months ]
    The average percentage of patient-reported pain relief at 3,6 and 12 months.

  3. Leg pain [ Time Frame: 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

  4. Quality of life measure [ Time Frame: 12 months ]
    Change from baseline in quality of life at 3, 6 and 12 months will be assessed using the EQ-5D-5L questionnaire.

  5. Pain Inventory [ Time Frame: 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.

  6. Global impression of change in health status [ Time Frame: 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".


Other Outcome Measures:
  1. Patients Work Status [ Time Frame: 12 months ]
    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.

  2. Device Safety [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05301816


Contacts
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Contact: Don Middlebrook 1 (650) 433 2218 don.middlebrook@nevro.com
Contact: Manish Bharara, PhD 1 (650) 785 1061 manish.bharara@nevro.com

Locations
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United States, Alaska
Neuroversion, Inc. Recruiting
Anchorage, Alaska, United States, 99508
Contact: Deborah Duricka, PhD    907-339-4655      
Principal Investigator: Luke Liu, MD         
United States, Michigan
Henry Ford Health Recruiting
Bloomfield, Michigan, United States, 48322
Contact: Rehnuma Newaz    248-325-2064    rnewaz1@hfhs.org   
Principal Investigator: Jason Schwalb, MD         
Michigan Pain Specialists Recruiting
Ypsilanti, Michigan, United States, 48198
Contact: Melisa Lockhart, RN    734-547-4868      
Principal Investigator: Edward Washabaugh, MD         
United States, Ohio
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Alberto Uribe, MD    614-293-0775      
Principal Investigator: Tristan Weaver, MD         
United States, Oklahoma
Clinical Investigations, LLC Recruiting
Edmond, Oklahoma, United States, 73013
Contact: Jennifer Witherby, RN    405-601-2325    scheduling@clinrad.org   
Principal Investigator: Douglas Beall, MD         
United States, Oregon
Columbia Pain Management Recruiting
Milwaukie, Oregon, United States, 97222
Contact: Cherie Flory, RN    541-386-9500 ext 219      
Principal Investigator: David Russo, MD         
Sub-Investigator: Vishal Khemlani, MD         
United States, Virginia
Virginia Interventional Pain & Spine Centers Recruiting
Roanoke, Virginia, United States, 24018
Contact: Jessica Pickel    540-777-0090      
Principal Investigator: Chheany W.C. Ung, MD         
Sponsors and Collaborators
Nevro Corp
Investigators
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Study Director: David Caraway, MD Chief Medical Officer, Nevro Corp
More Information
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Responsible Party: Nevro Corp
ClinicalTrials.gov Identifier: NCT05301816    
Other Study ID Numbers: CA2021-03 INT PDN-PM
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: January 17, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Nevro Corp:
Spinal Cord Stimulation (SCS)
Additional relevant MeSH terms:
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Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases