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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
Must not have
Patients must not have a diagnosis of a lower limb mononeuropathy, have had a lower limb amputation other than toes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have nerve damage, major amputations, or large ulcers on my legs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Global impression of change in health status
Leg pain
Pain Inventory
+3 more
Other study objectives
Device Safety
Patients Work Status

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
8 Previous Clinical Trials
1,322 Total Patients Enrolled
David Caraway, MDStudy DirectorChief Medical Officer, Nevro Corp
5 Previous Clinical Trials
786 Total Patients Enrolled

Media Library

Spinal Cord Stimulator (SCS) (Spinal Cord Stimulator) Clinical Trial Eligibility Overview. Trial Name: NCT05301816 — N/A
Diabetic Neuropathy Research Study Groups: IPG Activated
Diabetic Neuropathy Clinical Trial 2023: Spinal Cord Stimulator (SCS) Highlights & Side Effects. Trial Name: NCT05301816 — N/A
Spinal Cord Stimulator (SCS) (Spinal Cord Stimulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05301816 — N/A
~273 spots leftby Oct 2027
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