A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Clinical Outcomes and Pathology of Painful Diabetic Peripheral Neuropathy (pDPN)

Boston Scientific Corporation1 site in 1 country28 target enrollmentSeptember 22, 2022

ConditionsChronic Pain

InterventionsSpinal Cord Stimulation (SCS)

Overview

Phase: N/A
Intervention: Spinal Cord Stimulation (SCS)
Conditions: Chronic Pain
Sponsor: Boston Scientific Corporation
Enrollment: 28
Locations: 1
Primary Endpoint: Pain Relief in Limb Pain
Status: Active, Not Recruiting
Last Updated: 19 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 painful Diabetic Peripheral Neuropathy (pDPN).

Registry

clinicaltrials.gov

Start Date

September 22, 2022

End Date

April 1, 2026

Last Updated

19 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

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.

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.