Studies spinal cord stimulators for painful nerve damage in adults with diabetes
Observes spinal cord stimulators in adults with diabetes and painful nerve damage.
Key facts
- Who runs it
- University of Chicago
- Where
- Chicago, United StatesSee the site
- Trial code
- Registry title
- Diabetic Neuropathy in Spinal Cord Stimulator Patients
- Status
- Recruiting
- People taking part
- 25 people, planned
- Started
- 27 Jan 2022
- Expected to end
- 1 Dec 2026
- Type of study
- Observational
- Record updated
- 5 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 2 diabetes and painful nerve damage in the legs that other treatments have not helped. It tests a spinal cord stimulator.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes for more than 1 year, stage 3 or less. Painful diabetic nerve damage in the legs that does not respond to treatment. ABI index below 0.9.
- Earlier treatment
- The painful nerve damage must be refractory, meaning it has not responded to earlier treatment. The record gives no other prior treatment rules.
- Biomarker or test result
- ABI index <0.9.
Main reasons for not taking part
- Taking anticoagulants
- Active infection
- HbA1 above 10
- Psychiatric disorder or cognitive dysfunction
- On dialysis
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Illicit Drug Usage
- Surgery within the last 30 days
- Patients with active infections
- Psychiatric disorders and cognitive dysfunctions
- Ulcer of the lower extremities
- Patients on anticoagulants
- Patients with HbA1>10
- Patients on dialysis
- BMI>35.0
- Calcification of the peripheral arteries
Where in United States
- University of Chicago Medical CenterChicago, United StatesContact: Magdalena Anitescu, MD, PhDTaking people
About the trial
What the trial wants 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 changes induced by DM and improving arterial stiffness of the vessels of the lower extremity.
The group in the trial
- 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Studies spinal cord stimulators for painful nerve damage in adults with diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 February 2026