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
University of Chicago
Summary
The objective of this study is to assess the effect Spinal Cord Stimulators have toward improving vascular changes of diabetes mellitus in patients eligible for SCS placement based on their condition of painful diabetic neuropathy; we will evaluate improving their disability and quality of life, improving micro-circulatory changes induced by Diabetes Mellitus (DM), improving macro-circulatory changes induced by DM and improving arterial stiffness of the vessels of the lower extremity.
Description
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 d…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with DM type 2 of more than 1-year duration 2. DM stage 3 or less 3. Patients ≥18 years of age 4. Refractory painful diabetic peripheral neuropathy of the lower extremities 5. ABI index \<0.9 Exclusion Criteria: 1. Patients on anticoagulants 2. Patients with active infections 3. Patients with HbA1\>10 4. Psychiatric disorders and cognitive dysfunctions 5. Illicit Drug Usage 6. Patients on dialysis 7. BMI\>35.0 8. Surgery within the last 30 days 9. Ulcer of the lower extremities 10. Calcification of the peripheral arteries
Location
- University of Chicago Medical CenterChicago, Illinois