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Diabetic Neuropathy in Spinal Cord Stimulator Patients

Sponsored by University of Chicago

About this study

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.

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 of diabetic patients. Patients who have been diagnosed with DM type II for at least 1 year and refractory painful diabetic peripheral neuropathy of the lower extremities who are scheduled to receive a spinal cord stimulator may be enrolled in this study pending eligibly for all other criteria. Once eligibility and consent have been confirmed, each subject will go through a baseline visit where data will collected through a series of questionnaires, a clinical and psychological evaluation by a licensed professional. Subjects will be asked to come back for a series of vascular test prior to th…

Where this study is enrolling

Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.