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Diabetic Neuropathy in Spinal Cord Stimulator Patients

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.

ClinicalTrials.gov IDNCT04687215
PhaseNot Applicable
Enrollment25
SponsorUniversity of Chicago
Age18 Years
SexALL
I'm interested View official listing

Conditions studied

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

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.

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.