Clinical trial NCT05301816: PDN Post Market, Multicenter, Prospective, Global Clinical Study
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
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Neuropathy, Painful
Keywords: Spinal Cord Stimulation (SCS)
Lead sponsor: Nevro Corp
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Trial success rate/Responder rate
timeFrame: 2 weeks
measure: Patient-reported overall pain relief
timeFrame: 12 months
measure: Leg pain
timeFrame: 12 months
measure: Quality of life measure
timeFrame: 12 months
measure: Pain Inventory
timeFrame: 12 months
measure: Global impression of change in health status
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Patients Work Status
timeFrame: 12 months
measure: Device Safety
timeFrame: 12 months
Locations:
city: Anchorage
country: United States
facility: Neuroversion, Inc.
state: Alaska
city: Ann Arbor
country: United States
facility: Michigan Pain Specialists
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Health
state: Michigan
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Edmond
country: United States
facility: Clinical Investigations, LLC
state: Oklahoma
city: Milwaukie
country: United States
facility: Columbia Pain Management
state: Oregon
city: York
country: United States
facility: WellSpan Interventional Pain Specialists
state: Pennsylvania
city: Roanoke
country: United States
facility: Virginia Interventional Pain & Spine Centers
state: Virginia
Study officials:
affiliation: Chief Medical Officer, Nevro Corp
name: David Caraway, MD
role: STUDY_DIRECTOR
References: