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Active, Not Recruiting

NCT Number: NCT05301816

PDN Post Market, Multicenter, Prospective, Global Clinical Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Neuropathy, Painful Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuroversion, Inc., Anchorage, Alaska, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To participate in the study, patients must meet all the following inclusion criteria:

  • 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.
  • 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.
  • 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.
  • Be willing and capable of giving written informed consent.
  • 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:

  • 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
  • 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.
  • 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).

Treatment and study plan

Spinal Cord Stimulator (SCS)

Device

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nevro Corp

Industry

Registry information

Official study 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.

Acronym: PDN-PM

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Mar 31, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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