Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Painful Diabetic Peripheral Neuropathy (pDPN)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pa...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05302063
Start Date
September 22 2022
End Date
April 1 2026
Last Update
December 15 2025
Active Locations (1)
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1
Hospital La Paz
Madrid, Spain