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

Boston Scientific

Status

Active, not recruiting

Conditions

Chronic Pain

Treatments

Device: Spinal Cord Stimulation (SCS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05302063

A4105

Details and patient eligibility

About

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).

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.