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

Study 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).

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

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: Spinal Cord Stimulation (SCS)


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Cord Stimulation (SCS)<br>Boston Scientific Spinal Cord Stimulation Systems with multiple modalities | Device: Spinal Cord Stimulation (SCS)<br>* Boston Scientific Spinal Cord Stimulation Systems with multiple modalities<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 12 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 12 months follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Stimulation, Chronic Pain