NCT04687215 · University of Chicago
Diabetic Neuropathy in Spinal Cord Stimulator Patients
What this study is about
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.
View original scientific 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.
Primary outcome measures
Improve vascular changes
Time frame: 6 Weeks
Improve vascular changes (macroscopic: color, edema, ulceration, etc)
Vascular improvement on lower extremities with the Ankle Brachial Index (ABI)
Time frame: 6 weeks
Collect data on possible macrovascular improvement in lower extremities by performing the ABI test
Vascular improvement on lower extremities with the Toe Brachial Index (TBI)
Time frame: 6 Weeks
Collect data on possible macrovascular improvement in lower extremities by performing the TBI test
Vascular improvement on lower extremities with the Doppler Flowmetry
Time frame: 6 Weeks
Collect data on possible macrovascular improvement in lower extremities by performing the Doppler Flowmetry
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Patients on anticoagulants
- Patients with active infections
- Patients with HbA1\>10
- Psychiatric disorders and cognitive dysfunctions
- Illicit Drug Usage
- Patients on dialysis
- Surgery within the last 30 days
- Ulcer of the lower extremities
- Calcification of the peripheral arteries
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations