Diabetic Neuropathy in Spinal Cord Stimulator Patients
Recruiting · NCT04687215 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Chicago
View the official record on ClinicalTrials.gov →What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
- BMI\>35.0
- Surgery within the last 30 days
- Ulcer of the lower extremities
- Calcification of the peripheral arteries
Where it is running
1 location listed across 1 US state.
- University of Chicago Medical Center - Chicago, Illinois, United States