RecruitingNCT04687215

Diabetic Neuropathy in Spinal Cord Stimulator Patients

Spinal Cord Stimulation Improves Pain, Arterial Stiffness and Vascular Flow in Lower Extremities in Patients With Diabetes Mellitus Type II A Multidisciplinary Collaborative Prospective Study

Sponsor

University of Chicago

Enrollment

25 participants

Start Date

Jan 27, 2022

Study Type

OBSERVATIONAL

Conditions

Diabetes Mellitus Pain, Chronic Neuropathy Vascular Stiffness Neuropathic Pain Vascular Diseases Microvascular Changes

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether spinal cord stimulation (a device that sends mild electrical pulses to the spine) can help reduce nerve pain in the feet and legs of people with type 2 diabetes who have painful diabetic neuropathy that hasn't responded to other treatments. **You may be eligible if...** - You have had type 2 diabetes for more than 1 year - You have painful diabetic neuropathy in your lower limbs that has not responded to other treatments - You are 18 or older - Your ankle-brachial index (a measure of blood flow in the legs) is below 0.9 **You may NOT be eligible if...** - You are taking blood thinners (anticoagulants) - You have an active infection - Your blood sugar control is very poor (HbA1c above 10) - You have a psychiatric disorder or significant cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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