Status:
RECRUITING
Diabetic Neuropathy in Spinal Cord Stimulator Patients
Lead Sponsor:
University of Chicago
Conditions:
Diabetes Mellitus
Neuropathy
Eligibility:
All Genders
18+ years
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 ...
Detailed Description
This is a single-center, pilot study to investigate a preventative modality, spinal cord neuromodulation, that would contribute to reversing the physiologic changes that occur in the lower extremities...
Eligibility Criteria
Inclusion
- Patients with DM type 2 of more than 1-year duration
- DM stage 3 or less
- Patients ≥18 years of age
- Refractory painful diabetic peripheral neuropathy of the lower extremities
- ABI index \<0.9
Exclusion
- Patients on anticoagulants
- Patients with active infections
- Patients with HbA1\>10
- Psychiatric disorders and cognitive dysfunctions
- Illicit Drug Usage
- Patients on dialysis
- BMI\>35.0
- Surgery within the last 30 days
- Ulcer of the lower extremities
- Calcification of the peripheral arteries
Key Trial Info
Start Date :
January 27 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04687215
Start Date
January 27 2022
End Date
December 1 2026
Last Update
March 10 2025
Active Locations (1)
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1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637