Assessing the effects of spinal cord stimulators on diabetic neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.