A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Painful Diabetic Peripheral Ne… (NCT05302063) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Painful Diabetic Peripheral Neuropathy (pDPN)
Spain28 participantsStarted 2022-09-22
Plain-language summary
The purpose of the study is to evaluate the effects of stimulation parameters on clinical outcomes of Spinal Cord Stimulation (SCS) in the treatment of chronic, intractable limb pain resulting from painful Diabetic Peripheral Neuropathy (pDPN).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Clinical diagnosis of diabetes mellitus, according to International Diabetes guidelines.
* Willing and able to comply with all protocol-required procedures and assessments/evaluations.
* Eligible candidate for SCS from a surgical, cognitive, psychological and psychiatric standpoint per site's routine screening process and based on investigator judgement.
* Subject signed a valid, EC-approved informed consent form (ICF) provided in local language.
Key Exclusion Criteria:
* Primary etiology for lower limb neuropathic pain not due to Diabetic Peripheral Neuropathy (DPN).
* Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
* Currently implanted with an active implantable device(s) (e.g., pacemaker, drug pump).
* A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.