RECRUITING

Diabetic Neuropathy in Spinal Cord Stimulator Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-27
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04687215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients with DM type 2 of more than 1-year duration
  2. 2. DM stage 3 or less
  3. 3. Patients ≥18 years of age
  4. 4. Refractory painful diabetic peripheral neuropathy of the lower extremities
  5. 5. ABI index \<0.9
  1. 1. Patients on anticoagulants
  2. 2. Patients with active infections
  3. 3. Patients with HbA1\>10
  4. 4. Psychiatric disorders and cognitive dysfunctions
  5. 5. Illicit Drug Usage
  6. 6. Patients on dialysis
  7. 7. BMI\>35.0
  8. 8. Surgery within the last 30 days
  9. 9. Ulcer of the lower extremities
  10. 10. Calcification of the peripheral arteries

Contacts and Locations

Study Contact

Magdalena Anitescu, MD, PhD
CONTACT
(773) 834-5234
manitescu@dacc.uchicago.edu
Al McAuley, BS
CONTACT
773-834-3274
amcauley1@bsd.uchicago.edu

Principal Investigator

Magdalena Anitescu, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University of Chicago Medical Center
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Magdalena Anitescu, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-27
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2022-01-27
Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

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