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

Not Applicable

Active, not recruiting

• Conditions: Chronic Pain
• Interventions: Device: Spinal Cord Stimulation (SCS)

• Registration Number: NCT05302063
• Lead Sponsor: Boston Scientific Corporation

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Study Start: 2022-09-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation (SCS)	Spinal Cord Stimulation (SCS)	Boston Scientific Spinal Cord Stimulation Systems with multiple modalities

Primary Outcome Measures

Name	Time	Method
Pain Relief in Limb Pain	Up to 12 months follow up	Percent Pain Relief (PPR) in limb pain using a questionnaire where 100% is complete relief and 0% is no relief in pain compared with Baseline

Secondary Outcome Measures

Name	Time	Method
Global Impression of Change	Up to 12 months follow up	Patient global impression of change (PGI-C) at 3-, 6- and 12-Month Assessment Visit where patients use a seven-point scale to assess how much their condition has improved or worsened relative to their baseline. Subjects will rate themselves as: very much improved; much improved; minimally improved; no change; minimally worse; much worse; or very much worse.

Trial Locations

Locations (1)

Hospital La Paz; 🇪🇸 Madrid, Spain