Diabetic Neuropathy in Spinal Cord Stimulator Patients
RecruitingNCT04687215
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Diabetes Mellitus
- Neuropathy
- Neuropathic Pain
- Vascular Diseases
- Vascular Stiffness
- Microvascular Changes
- Pain, Chronic
- Sponsor
- University of Chicago
- Start date
- 2022-01-27
- Primary completion
- 2026-08-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04687215