Recruiting

Spinal Cord Stimulator

Sponsor:

University of Chicago

Code:

NCT04687215

Conditions

Diabetes Mellitus

Neuropathy

Neuropathic Pain

Vascular Diseases

Vascular Stiffness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Diabetes Mellitus

Neuropathy

Neuropathic Pain

Vascular Diseases

Vascular Stiffness

Study ID

NCT04687215

Start date

Jan 27, 2022

Status verified date

Feb, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Diabetic patients receiving a spinal cord stimulator

Patients that have been seen in the diabetic foot clinic will be evaluated for participation in the study once they have been referred to one of our pain clinics.

Primary outcome measure

  • Improve vascular changes [ Time Frame: 6 Weeks ]
  • Vascular improvement on lower extremities with the Ankle Brachial Index (ABI) [ Time Frame: 6 weeks ]
  • Vascular improvement on lower extremities with the Toe Brachial Index (TBI) [ Time Frame: 6 Weeks ]
  • Vascular improvement on lower extremities with the Doppler Flowmetry [ Time Frame: 6 Weeks ]

Central Contacts and Locations

Central contacts

Magdalena Anitescu, MD, PhD

(773) 834-5234manitescu@dacc.uchicago.edu

Al McAuley, BS

773-834-3274amcauley1@bsd.uchicago.edu

Locations

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Magdalena Anitescu, MD, PhD

7738345234MAnitescu@dacc.uchicago.edu

Edward Fox, BA

7738345234efox1@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-02-05.