PDN Post Market, Multicenter, Prospective, Global Clinical Study

Last updated: November 5, 2024
Sponsor: Nevro Corp
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Spinal Cord Stimulator (SCS)

Clinical Study ID

NCT05301816
CA2021-03 INT PDN-PM
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 countrydiabetes association guidelines, as well as painful diabetic neuropathy (PDN) of thelower limbs refractory to conventional medical management.

  2. Average pain intensity (over the last 7 days) of ≥5 out of 10 cm on the VisualAnalog Scale (VAS) in the lower limbs at enrollment/baseline.

  3. The clinical decision has been made to provide treatment using the Nevro Spinal CordStimulation 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 andattend all scheduled visits.

Exclusion

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 orperoneal neuropathies), have had a lower limb amputation other than toes, or havelarge (≥3 cm) and/or gangrenous ulcers of the lower limbs

  2. Have a medical condition or diagnosis that is inconsistent with Nevro's SCS Systemguidelines in the Physician's Manual for the relevant country, or as per standardclinical practice.

  3. Have a medical condition or pain in other areas, not intended to be treated in thisstudy, that could interfere with study procedures, accurate pain reporting, and/orconfound the evaluation of study endpoints, as determined by the Investigator (suchas primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis,peripheral vascular disease, or small vessel disease).

Study Design

Total Participants: 497
Treatment Group(s): 1
Primary Treatment: Spinal Cord Stimulator (SCS)
Phase:
Study Start date:
July 05, 2022
Estimated Completion Date:
October 31, 2028

Connect with a study center

  • Neuroversion, Inc.

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Nevro Corp

    Redwood City, California 94065
    United States

    Site Not Available

  • Michigan Pain Specialists

    Ann Arbor, Michigan 48108
    United States

    Active - Recruiting

  • Henry Ford Health

    Bloomfield, Michigan 48322
    United States

    Site Not Available

  • Henry Ford Health

    West Bloomfield, Michigan 48322
    United States

    Active - Recruiting

  • Michigan Pain Specialists

    Ypsilanti, Michigan 48198
    United States

    Site Not Available

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Clinical Investigations, LLC

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Columbia Pain Management

    Milwaukie, Oregon 97222
    United States

    Active - Recruiting

  • WellSpan Interventional Pain Specialists

    York, Pennsylvania 17402
    United States

    Active - Recruiting

  • Virginia Interventional Pain & Spine Centers

    Roanoke, Virginia 24018
    United States

    Active - Recruiting

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