NCT04687215 Diabetic Neuropathy in Spinal Cord Stimulator Patients
| NCT ID | NCT04687215 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-01-27 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2022-01-27 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Magdalena Anitescu, MD, PhD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT04687215 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04687215 currently recruiting?
Yes, NCT04687215 is actively recruiting participants. Contact the research team at manitescu@dacc.uchicago.edu for enrollment information.
Where is the NCT04687215 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT04687215 clinical trial?
NCT04687215 is sponsored by University of Chicago. The principal investigator is Magdalena Anitescu, MD, PhD at University of Chicago. The trial plans to enroll 25 participants.
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