Shocking nerve pain away: new device trial for diabetic neuropathy

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has been clinically diagnosed with diabetes, according to the American Diabetes Association guidelines, as well as painful diabetic neuropathy (PDN) of the lower limbs. * Has pain intensity (over the last 7 days) of ≥5 out of 10 cm on the Visual Analog Scale (VAS) in the lower limbs at both the Enrollment and Baseline Visits. * Has PDN symptoms that have been present ≥12 months. * Is currently taking or has tried in the past a gabapentinoid and at least one other class of analgesic with insufficient pain relief or intolerable side effects. * Has been on a stable analgesic regimen, as determined by the Investigator, for at least 30 days prior to assessing pain intensity as described in inclusion criterion #2. * Has painful diabetic sensorimotor polyneuropathy confirmed by modified Toronto Clinical Neuropathy Score (mTCNS) \>5 at enrollment. The total score must include presence of foot pain (≥1) and sensory exam findings (≥ 2). * Has hemoglobin A1c ≤10% as measured at enrollment. * Is 22 years of age or older at the time of enrollment. * Is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the study physician. * Is willing to and capable of giving written informed consent. * Is willing and able to comply with study-related requirements and procedures and attend all scheduled visits. Exclusion Criteria: * Has a diagnosis of a lower limb mononeuropathy (e.g., causalgia, tibial or peroneal neuropathies), has had a lower limb amputation other than toes due to diabetes, or has large (≥3 cm) and/or gangrenous ulcers or active infection of the lower limbs. * Has an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper limbs due to diabetic neuropathy at enrollment. * Has a history of glycemia-related hospitalizations or emergency ward visits including ketoacidosis, hyperosmolar state, severe hypoglycemia in the previous 6 months. * Uses anticoagulants or antiplatelet agents that cannot be temporarily discontinued prior to the procedure. * Has unstable cardiovascular disease, including untreated cardiac arrhythmias, myocardial infarction within last 12 months, New York Heart Association (NYHA) Functional Class III or IV heart failure. * Is currently prescribed a daily opioid dosage \> 120 mg morphine equivalents. * Has a medical condition or diagnosis that is inconsistent with the Senza System guidelines in the Physician's Manual or as per standard clinical practice. * Has a medical condition or pain in other area(s), not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis, critical limb ischemia due to peripheral vascular disease or small vessel disease). * Has prior experience with SCS, dorsal root ganglion (DRG) stimulation, peripheral nerve field stimulation (PNfS), or peripheral nerve stimulation (PNS) for chronic intractable pain. * Has an existing drug pump and/or another active implantable device such as a pacemaker (ok to have an insulin pump or continuous glucose monitor that remains externalized). * Has a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza System guidelines in the Physician's Manual. * Has a life expectancy of less than one year. * Has a local infection at the anticipated surgical entry site or an active systemic infection. * Is pregnant or plans to become pregnant during the study (participants of child-bearing potential that are sexually active must use a reliable form of birth control). * Has had within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs. * Is concomitantly participating in another interventional clinical study. * Is involved in an injury claim for study-related chronic pain that is under current litigation. * Is a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to study-related chronic pain. * Has a pending or approved worker's compensation claim for study-related chronic pain. * Has evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome, as determined by the investigator in the last 12 months. * Has a BMI \> 45 at enrollment.