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Diabetic Neuropathy in Spinal Cord Stimulator Patients

RECRUITINGSponsored by University of Chicago
Actively Recruiting
SponsorUniversity of Chicago
Started2022-01-27
Est. completion2026-08-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT04687215

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions8

DiabetesDiabetes MellitusMicrovascular ChangesNeuropathic PainNeuropathyPain, ChronicVascular DiseasesVascular Stiffness

Locations1 site

University of Chicago Medical Center
Chicago, Illinois, 60637
Magdalena Anitescu, MD, PhD7738345234MAnitescu@dacc.uchicago.edu

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