Actively Recruiting
PDN Post Market, Multicenter, Prospective, Global Clinical Study
Led by Nevro Corp · Updated on 2024-11-07
497
Participants Needed
8
Research Sites
325 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PDN Post Market, Multicenter, Prospective, Global Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed with diabetes and painful diabetic neuropathy of the lower limbs not responding to usual medical treatments
- Average leg pain intensity of 5 or higher out of 10 on the Visual Analog Scale in the last 7 days
- Clinical decision made to treat using Nevro Spinal Cord Stimulation including 10 kHz therapy before enrollment
- Willing and able to provide written informed consent
- Willing and able to follow study procedures and attend all scheduled visits
You will not qualify if you...
- Diagnosis of lower limb mononeuropathy such as causalgia or tibial/peroneal neuropathies
- Previous lower limb amputation other than toes
- Presence of large (3 cm or larger) or gangrenous ulcers on lower limbs
- Medical conditions inconsistent with Nevro's SCS System guidelines or standard clinical practice
- Other medical conditions or pain in areas not treated in this study that could interfere with study procedures or pain reporting, such as primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis, peripheral vascular disease, or small vessel disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Neuroversion, Inc.
Anchorage, Alaska, United States, 99508
Active, Not Recruiting
2
Michigan Pain Specialists
Ann Arbor, Michigan, United States, 48108
Actively Recruiting
3
Henry Ford Health
West Bloomfield, Michigan, United States, 48322
Actively Recruiting
4
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
5
Clinical Investigations, LLC
Edmond, Oklahoma, United States, 73013
Active, Not Recruiting
6
Columbia Pain Management
Milwaukie, Oregon, United States, 97222
Actively Recruiting
7
WellSpan Interventional Pain Specialists
York, Pennsylvania, United States, 17402
Actively Recruiting
8
Virginia Interventional Pain & Spine Centers
Roanoke, Virginia, United States, 24018
Actively Recruiting
Research Team
K
Kerry Bradley
CONTACT
M
Manish Bharara, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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