Assessing the effects of spinal cord stimulators on diabetic neuropathy
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 study is testing if spinal cord stimulators can help people with diabetes and painful nerve damage feel better and improve their overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04687215 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how spinal cord stimulators can improve vascular changes in patients with diabetes mellitus who suffer from painful diabetic neuropathy. It will involve a single-center pilot approach at the University of Chicago Medical Center, where eligible patients will undergo a series of assessments, including questionnaires and vascular tests, prior to receiving the spinal cord stimulator. The study focuses on measuring improvements in disability, quality of life, and vascular health in the lower extremities of diabetic patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with type 2 diabetes for over a year and refractory painful diabetic peripheral neuropathy.
Not a fit: Patients with active infections, significant psychiatric disorders, or those on anticoagulants will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of diabetic neuropathy and enhanced quality of life for patients with diabetes.
How similar studies have performed: While spinal cord stimulation has been explored in various contexts, this specific approach to address vascular changes in diabetic patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Magdalena Anitescu, MD, PhD — University of Chicago
- Study coordinator: Magdalena Anitescu, MD, PhD
- Email: manitescu@dacc.uchicago.edu
- Phone: (773) 834-5234
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.