PDN Post Market, Multicenter, Prospective, Global Clinical Study

Diabetic Neuropathy, Painful Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05301816
• Other study ID #: CA2021-03 INT PDN-PM
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: March 2027

Study information

• Verified date: January 2024
• Source: Nevro Corp
• Contact: Don Middlebrook
• Phone: 1 (650) 433 2218
• Email: don.middlebrook[@]nevro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 497
• Est. completion date: March 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy, Painful

Intervention

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.

Locations

Country	Name	City	State
United States	Neuroversion, Inc.	Anchorage	Alaska
United States	Henry Ford Health	Bloomfield	Michigan
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Clinical Investigations, LLC	Edmond	Oklahoma
United States	Columbia Pain Management	Milwaukie	Oregon
United States	Virginia Interventional Pain & Spine Centers	Roanoke	Virginia
United States	Michigan Pain Specialists	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Nevro Corp

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients Work Status	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.	12 months
Other	Device Safety	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.	12 months
Primary	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
Primary	Patient-reported overall pain relief	The average percentage of patient-reported pain relief at 3,6 and 12 months.	12 months
Primary	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
Primary	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
Primary	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
Primary	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