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

NCT ID: NCT05302063

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-22

Study Completion Date

2026-04-30

Brief Summary

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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

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Conditions

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Chronic Pain

Keywords

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Spinal Cord Stimulation Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spinal Cord Stimulation (SCS)

Boston Scientific Spinal Cord Stimulation Systems with multiple modalities

Group Type EXPERIMENTAL

Spinal Cord Stimulation (SCS)

Intervention Type DEVICE

Boston Scientific Spinal Cord Stimulation Systems with multiple modalities

Interventions

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Spinal Cord Stimulation (SCS)

Boston Scientific Spinal Cord Stimulation Systems with multiple modalities

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Bloom Lyons

Role: STUDY_DIRECTOR

Boston Scientific Neuromodulation Corporation

Locations

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Hospital La Paz

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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A4105

Identifier Type: -

Identifier Source: org_study_id