Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy

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 neurop…