Spinal Cord Stimulation Improves Pain, Arterial Stiffness and Vascular Flow in Lower Extremities in Patients With Diabetes Mellitus Type II A Multidisciplinary Collaborative Prospective Study

This is a single-center, pilot study to investigate a preventative modality, spinal cord neuromodulation, that would contribute to reversing the physiologic changes that occur in the lower extremities of diabetic patients. Patients who have been diagnosed with DM type II for at least 1 year and refractory painful diabetic peripheral neuropathy of the lower extremities who are scheduled to receive a spinal cord stimulator may be enrolled in this study pending eligibly for all other criteria.

Once eligibility and consent have been confirmed, each subject will go through a baseline visit where data will collected through a series of questionnaires, a clinical and psychological evaluation by a licensed professional. Subjects will be asked to come back for a series of vascular test prior to their device implantation. This vascular testing will be done at the vascular lab at the University of Chicago Medical Center by trained vascular physicians and techs.

Prior to any study related procedures, all subjects must first sign the approved ICF. This will be performed by the PI or an approved member of the study staff who has been delegated by the PI do so and in a private setting with ample time given to the subject to review and ask any questions regarding the study. Once the ICF has been signed, a copy will be given to the subject and the original will be placed in their research or medical chart.

Background Data

Once the ICF has been complete, demographic data such as name, age, gender will be collected. Along with demographic information, we will collect medical, surgical and medication history for each subject at the initial baseline visit.