NCT05301816

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
497

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Jul 2022Oct 2028

First Submitted

Initial submission to the registry

February 11, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 5, 2022

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

5.2 years

First QC Date

February 11, 2022

Last Update Submit

November 5, 2024

Conditions

Diabetic Neuropathy, Painful

Keywords

Spinal Cord Stimulation (SCS)

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Patients Work Status

    12 months

  • Device Safety

    12 months

Study Arms (1)

IPG Activated

EXPERIMENTAL

The group of participants who have had a successful trial (\>50% pain relief) during the trial phase

Device: Spinal Cord Stimulator (SCS)

Interventions

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.

IPG Activated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Neuroversion, Inc.

Anchorage, Alaska, 99508, United States

ACTIVE NOT RECRUITING

Michigan Pain Specialists

Ann Arbor, Michigan, 48108, United States

RECRUITING

Henry Ford Health

West Bloomfield, Michigan, 48322, United States

RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Clinical Investigations, LLC

Edmond, Oklahoma, 73013, United States

ACTIVE NOT RECRUITING

Columbia Pain Management

Milwaukie, Oregon, 97222, United States

RECRUITING

WellSpan Interventional Pain Specialists

York, Pennsylvania, 17402, United States

RECRUITING

Virginia Interventional Pain & Spine Centers

Roanoke, Virginia, 24018, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • David Caraway, MD

    Chief Medical Officer, Nevro Corp

    STUDY DIRECTOR

Central Study Contacts

Kerry Bradley

CONTACT

1-650-251-0005bradley@nevro.com

Manish Bharara, PhD

CONTACT

1 (650) 785 1061manish.bharara@nevro.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2022

First Posted

March 31, 2022

Study Start

July 5, 2022

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

November 7, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(8)