Diabetic Neuropathy in Spinal Cord Stimulator Patients

NCT04687215 | Recruiting

• 1 other identifier: IRB20-1098
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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; Microvascular Changes; Pain, Chronic

Outcome Measures

Primary Outcomes (4)

• Improve vascular changes

  Improve vascular changes (macroscopic: color, edema, ulceration, etc)

  6 Weeks

• Vascular improvement on lower extremities with the Ankle Brachial Index (ABI)

  Collect data on possible macrovascular improvement in lower extremities by performing the ABI test

  6 weeks

• Vascular improvement on lower extremities with the Toe Brachial Index (TBI)

  Collect data on possible macrovascular improvement in lower extremities by performing the TBI test

  6 Weeks

• Vascular improvement on lower extremities with the Doppler Flowmetry

  Collect data on possible macrovascular improvement in lower extremities by performing the Doppler Flowmetry

  6 Weeks

Secondary Outcomes (9)

• Show Improvement in pain in patients with painful diabetic neuropathy

  6 Weeks

• Patients' Global Impression of Change (PGIC)

  6 Weeks

• Health-related quality of life (H-RQol)

  6 Weeks

• Oswestry Low Back Pain Disability Questionnaire (ODI)

  6 Weeks

• Short-form McGill Pain Questionnaire ( SF-MPQ)

  6 Weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. The study will focus on enrolling patients in early stages of DM 2 with no neuropathic ulcers or arterial calcification.

You may qualify if:

• 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

You may not qualify if:

• Patients on anticoagulants
• Patients with active infections
• Patients with HbA1\>10
• Psychiatric disorders and cognitive dysfunctions
• Illicit Drug Usage
• Patients on dialysis
• BMI\>35.0
• Surgery within the last 30 days
• Ulcer of the lower extremities
• Calcification of the peripheral arteries

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Neuralgia; Vascular Diseases; Chronic Pain

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases

Study Officials

• Magdalena Anitescu, MD, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena Anitescu, MD, PhD

CONTACT

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

Al McAuley, BS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 29, 2020
• Study Start: January 27, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)