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

N/AActive Not RecruitingNCT05302063

Boston Scientific Corporation28 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

Spinal Cord Stimulation (SCS)DEVICE

Boston Scientific Spinal Cord Stimulation Systems with multiple modalities

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital La Paz

Madrid, Spain

Outcomes

Primary Outcomes

Pain Relief in Limb Pain

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

Time frame: Up to 12 months follow up

Secondary Outcomes

Global Impression of Change

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.

Time frame: Up to 12 months follow up

Data from ClinicalTrials.gov

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