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NCT04687215Recruiting

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

Source: ClinicalTrials.gov · Last updated 5 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
25 (estimated)
First submitted
9 Dec 2020
Start date
27 Jan 2022
Primary completion date
1 Aug 2026
Lead sponsor
University of Chicago
NCT number
NCT04687215

What you commit to

  • Study type: Observational
  • Planned participants: 25
  • From 27 Jan 2022 to the primary completion date, 1 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Illicit Drug Usage
  • Surgery within the last 30 days

Other illness

  • Patients with active infections
  • Psychiatric disorders and cognitive dysfunctions
  • Ulcer of the lower extremities

Other

  • Patients on anticoagulants
  • Patients with HbA1\>10
  • Patients on dialysis
  • BMI\>35.0
  • Calcification of the peripheral arteries

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Chicago Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.