Your session is about to expire
← Back to Search
Spinal Cord Stimulator
Spinal Cord Stimulator for Diabetic Neuropathy (PDN-PM Trial)
N/A
Recruiting
Research Sponsored by Nevro Corp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
PDN-PM Trial Summary
This trial will study Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (PDN).
Who is the study for?
This trial is for individuals with chronic leg pain due to painful diabetic neuropathy (PDN) who haven't found relief through standard treatments. Participants must have a consistent pain intensity of ≥5 out of 10 on the Visual Analog Scale, be diagnosed with diabetes per local guidelines, and be able to give informed consent and follow study procedures.Check my eligibility
What is being tested?
The study is observing the effectiveness of Nevro's Spinal Cord Stimulation (SCS) therapy at a frequency of 10 kHz in patients suffering from PDN. It's an observational global study that involves interdisciplinary treatment by pairing diabetes management teams with pain physicians.See study design
What are the potential side effects?
While specific side effects are not listed here, spinal cord stimulation can generally cause discomfort at the implant site, unwanted changes in stimulation related to movements or posture, and potential infection risks associated with any surgical procedure.
PDN-PM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have diabetes and experience severe leg pain due to nerve damage that hasn’t improved with standard treatments.
Select...
I am approved for Nevro Spinal Cord Stimulation treatment.
Select...
My average leg pain over the last week is 5 or more on a scale of 1 to 10.
Select...
I am willing and able to follow the study's requirements and attend all visits.
Select...
I have diabetes and experience severe leg pain due to nerve damage that hasn’t improved with standard treatments.
Select...
My average leg pain over the last week is 5 or more on a scale of 10.
PDN-PM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Global impression of change in health status
Leg pain
Pain Inventory
+3 moreOther outcome measures
Device Safety
Patients Work Status
PDN-PM Trial Design
1Treatment groups
Experimental Treatment
Group I: IPG ActivatedExperimental Treatment1 Intervention
The group of participants who have had a successful trial (>50% pain relief) during the trial phase
Find a Location
Who is running the clinical trial?
Nevro CorpLead Sponsor
7 Previous Clinical Trials
1,400 Total Patients Enrolled
David Caraway, MDStudy DirectorChief Medical Officer, Nevro Corp
5 Previous Clinical Trials
786 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am approved for Nevro Spinal Cord Stimulation treatment before joining the study.I have diabetes and experience severe leg pain due to nerve damage that hasn’t improved with standard treatments.I am approved for Nevro Spinal Cord Stimulation treatment.My average leg pain over the last week is 5 or more on a scale of 1 to 10.I am willing and able to sign a consent form.I am willing and able to sign a consent form.I am willing and able to follow the study's requirements and attend all visits.I have diabetes and experience severe leg pain due to nerve damage that hasn’t improved with standard treatments.I do not have nerve damage, major amputations, or large ulcers on my legs.I am willing and able to follow the study's requirements and attend all visits.My average leg pain over the last week is 5 or more on a scale of 10.
Research Study Groups:
This trial has the following groups:- Group 1: IPG Activated
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare institutions are engaged in carrying out this clinical trial?
"This medical study has 7 participating sites, such as Nevro Corp in Redwood City, Neuroversion Inc. in Anchorage and Virginia Interventional Pain & Spine Centers from Roanoke amongst other establishments."
Answered by AI
How many individuals are being inducted into this research project?
"Affirmative. The digital records on clinicaltrials.gov demonstrate that this research is currently seeking participants; it was first advertised on July 1st 2021 and the posted details have been amended as recently as June 28th 2022. This study aims to recruit a total of 497 subjects from 7 distinct medical sites."
Answered by AI
Are there presently any vacancies for participants in this trial?
"Affirmative. Clinicaltrials.gov records show that this research study, which was initially released on July 1st 2022, is currently open for recruitment and has since been modified on June 28th 2022. 497 participants are necessary to be enrolled from 7 clinical sites."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
California
Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Nevro Corp
Virginia Interventional Pain & Spine Centers
Henry Ford Health
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger