BurstDRTM Spinal Cord Dorsal Column Stimulation for Painful Diabetic Neuropathy

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
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• 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

• Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator

• Be on a stable analgesic regimen, as determined by the Investigator, for at least 30 days prior to assessing pain intensity, and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device

• Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator

Locations
United States
Wisconsin
Aurora Health Oshkosh
RECRUITING
Oshkosh
Contact Information
Primary
Merve Buluk Figueira, MS
merve.figueira@aah.org
9204561551
Time Frame
Start Date: 2023-07-03
Estimated Completion Date: 2027-03-03
Participants
Target number of participants: 40
Treatments
PDN treated with SCS and CMM
Painful diabetic neuropathy patients treated with burst stimulation along with conservative medical management as part of regular medical care.
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov