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

Primary Purpose

Diabetic Neuropathy, Painful

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Spinal Cord Stimulator (SCS)

About this trial

This is an interventional treatment trial for Diabetic Neuropathy, Painful focused on measuring Spinal Cord Stimulation (SCS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Neuroversion, Inc.Recruiting
Michigan Pain SpecialistsRecruiting
Ohio State University Wexner Medical CenterRecruiting
Clinical Investigations, LLCRecruiting
Columbia Pain ManagementRecruiting
Virginia Interventional Pain & Spine CentersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IPG Activated

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Patient-reported overall pain relief

The average percentage of patient-reported pain relief at 3,6 and 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

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.

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.

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".

Secondary Outcome Measures

Full Information

NCT ID

NCT05301816

First Posted

February 11, 2022

Last Updated

June 28, 2022

Sponsor

Nevro Corp

1. Study Identification

Unique Protocol Identification Number

NCT05301816

Brief Title

PDN Post Market, Multicenter, Prospective, Global Clinical Study

Acronym

PDN-PM

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 2022 (Anticipated)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nevro Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathy, Painful

Keywords

Spinal Cord Stimulation (SCS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

497 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IPG Activated

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Spinal Cord Stimulator (SCS)

Intervention Description

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 Outcome Measure Information:

Title

Trial success rate/Responder rate

Description

Percentage of patients with a successful trial phase (responder rate) i.e. at least 50% reduction in patient-reported overall pain relief.

Time Frame

2 weeks

Title

Patient-reported overall pain relief

Description

The average percentage of patient-reported pain relief at 3,6 and 12 months.

Time Frame

12 months

Title

Leg pain

Description

Time Frame

12 months

Title

Quality of life measure

Description

Change from baseline in quality of life at 3, 6 and 12 months will be assessed using the EQ-5D-5L questionnaire.

Time Frame

12 months

Title

Pain Inventory

Description

Time Frame

12 months

Title

Global impression of change in health status

Description

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Patients Work Status

Description

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.

Time Frame

12 months

Title

Device Safety

Description

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.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Don Middlebrook

Phone

1 (650) 433 2218

don.middlebrook@nevro.com

First Name & Middle Initial & Last Name or Official Title & Degree

Manish Bharara, PhD

Phone

1 (650) 785 1061

manish.bharara@nevro.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Caraway, MD

Organizational Affiliation

Chief Medical Officer, Nevro Corp

Official's Role

Study Director

Facility Information:

Facility Name

Neuroversion, Inc.

City

Anchorage

State/Province

Alaska

ZIP/Postal Code

99508

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Deborah Duricka, PhD

Phone

907-339-4655

First Name & Middle Initial & Last Name & Degree

Luke Liu, MD

Facility Name

Michigan Pain Specialists

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48198

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melisa Lockhart, RN

Phone

734-547-4868

First Name & Middle Initial & Last Name & Degree

Edward Washabaugh, MD

Facility Name

Ohio State University Wexner Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alberto Uribe, MD

Phone

614-293-0775

First Name & Middle Initial & Last Name & Degree

Tristan Weaver, MD

Facility Name

Clinical Investigations, LLC

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73013

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Witherby, RN

Phone

405-601-2325

scheduling@clinrad.org

First Name & Middle Initial & Last Name & Degree

Douglas Beall, MD

Facility Name

Columbia Pain Management

City

Milwaukie

State/Province

Oregon

ZIP/Postal Code

97222

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cherie Flory, RN

Phone

541-386-9500

Ext

219

First Name & Middle Initial & Last Name & Degree

David Russo, MD

First Name & Middle Initial & Last Name & Degree

Vishal Khemlani, MD

Facility Name

Virginia Interventional Pain & Spine Centers

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24018

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica Pickel

Phone

540-777-0090

First Name & Middle Initial & Last Name & Degree

Chheany W.C. Ung, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

PDN Post Market, Multicenter, Prospective, Global Clinical Study

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