BurstDRTM Spinal Cord Dorsal Column Stimulation for Painful Diabetic Neuropathy

Wake Forest University Health Sciences1 site in 1 country6 target enrollmentJuly 3, 2023

ConditionsPainful Diabetic Neuropathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Painful Diabetic Neuropathy
Sponsor: Wake Forest University Health Sciences
Enrollment: 6
Locations: 1
Primary Endpoint: Average change from baseline to 3 months in treatment responder rates
Status: Terminated
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to demonstrate treatment outcomes of Painful Diabetic Neuropathy (PDN) patients treated with BurstDRTM Spinal Cord Dorsal Column Stimulator (SCS) along with conservative medical management per standard of care.

Detailed Description

In this study, we aim to systematically collect real world, observational and prospective data on the safety and effectiveness of an SCS system for the management of PDN. This study will provide, to the best of our knowledge, the first clinical, real world, prospective data in treatment of PDN with an SCS system.

Registry

clinicaltrials.gov

Start Date

July 3, 2023

End Date

October 6, 2025

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Wake Forest University Health Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of lower extremity Painful Diabetic Neuropathy (PDN) with symptoms for at least a year prior to signing the consent form
•PDN refractory to FDA approved medications: duloxetine, pregabalin, tapentadol, and capscaicin
•Lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS)
•HbA1c ≤10%
•BMI \<45 kg/m2
•Be 22 years of age or older at the time of enrollment
•Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
•Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English
•Be willing and capable of giving informed consent
•Be willing and able to comply with study-related requirements, procedures, and scheduled visits

Exclusion Criteria

•Current daily opioid dosage greater than 120 mg morphine equivalents
•Have an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper extremities due to diabetic neuropathy at enrollment
•Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial or peroneal neuropathies), have had a lower limb amputation other than toes due to diabetes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.
•Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury, as determined by the Investigator
•Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure, as determined clinically by the Investigator
•Be benefitting from an interventional procedure and/or surgery to treat lower limb pain (Subjects should be enrolled at least 30 days from last benefit).
•Have an existing intrathecal pain pump and/or another active implantable device such as a pacemaker
•Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with ProclaimTM system guidelines in the Physician's Manual
•Have either a metastatic malignant neoplasm or untreated local malignant neoplasm
•Have a life expectancy of less than one year