Phase
Condition
N/ATreatment
Spinal Cord Stimulator (SCS)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
To participate in the study, patients must meet all the following inclusion criteria:
Have been clinically diagnosed with diabetes, according to the local countrydiabetes association guidelines, as well as painful diabetic neuropathy (PDN) of thelower limbs refractory to conventional medical management.
Average pain intensity (over the last 7 days) of ≥5 out of 10 cm on the VisualAnalog Scale (VAS) in the lower limbs at enrollment/baseline.
The clinical decision has been made to provide treatment using the Nevro Spinal CordStimulation that includes 10 kHz therapy prior to enrollment in the study.
Be willing and capable of giving written informed consent.
Be willing and able to comply with study-related requirements and procedures andattend all scheduled visits.
Exclusion
Exclusion Criteria:
To participate in the study, patients must not meet any of the following exclusion criteria:
Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial orperoneal neuropathies), have had a lower limb amputation other than toes, or havelarge (≥3 cm) and/or gangrenous ulcers of the lower limbs
Have a medical condition or diagnosis that is inconsistent with Nevro's SCS Systemguidelines in the Physician's Manual for the relevant country, or as per standardclinical practice.
Have a medical condition or pain in other areas, not intended to be treated in thisstudy, that could interfere with study procedures, accurate pain reporting, and/orconfound the evaluation of study endpoints, as determined by the Investigator (suchas primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis,peripheral vascular disease, or small vessel disease).
Study Design
Connect with a study center
Neuroversion, Inc.
Anchorage, Alaska 99508
United StatesSite Not Available
Nevro Corp
Redwood City, California 94065
United StatesSite Not Available
Michigan Pain Specialists
Ann Arbor, Michigan 48108
United StatesActive - Recruiting
Henry Ford Health
Bloomfield, Michigan 48322
United StatesSite Not Available
Henry Ford Health
West Bloomfield, Michigan 48322
United StatesActive - Recruiting
Michigan Pain Specialists
Ypsilanti, Michigan 48198
United StatesSite Not Available
Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesActive - Recruiting
Clinical Investigations, LLC
Edmond, Oklahoma 73013
United StatesSite Not Available
Columbia Pain Management
Milwaukie, Oregon 97222
United StatesActive - Recruiting
WellSpan Interventional Pain Specialists
York, Pennsylvania 17402
United StatesActive - Recruiting
Virginia Interventional Pain & Spine Centers
Roanoke, Virginia 24018
United StatesActive - Recruiting
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