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Diabetic Neuropathy in Spinal Cord Stimulator Patients

Recruitingn/aAges 18 Years - anyAllUniversity of Chicago
NCT04687215 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
University of Chicago Medical Center
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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