No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
25 (estimated)
Sponsor
University of Chicago · Other
Who this trial is looking for
This trial is looking for adults with painful diabetic neuropathy who have had type 2 diabetes for more than a year. Participants will receive spinal cord stimulation to help improve their pain and overall quality of life.
Are You a Good Fit for This Trial?
Must not be takingAnticoagulants
You may be able to join if
I have been diagnosed with type 2 diabetes for more than 1 year.
I am at stage 3 diabetes or less.
I am at least 18 years old.
I have painful diabetic peripheral neuropathy in my legs.
My ankle-brachial index (ABI) is less than 0.9.
You may not be able to join if
I am currently taking anticoagulants.
I have an active infection.
My HbA1c level is over 10.
I have a psychiatric disorder or cognitive dysfunction.
I use illicit drugs.
I am on dialysis.
My body mass index (BMI) is over 35.
I have had surgery in the last 30 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 chan…
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.
Trial Locations
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State
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Status
Eligibility Criteria
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…
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
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