Trials / Terminated
TerminatedNCT05985291
BurstDR Stimulation for Painful Diabetic Neuropathy
BurstDRTM Spinal Cord Dorsal Column Stimulation for Painful Diabetic Neuropathy
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 6 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | SCS in combination with CMM | Subjects receiving BurstDR spinal cord dorsal column stimulation in combination with conservative medical management for the treatment of painful diabetic neuropathy as part of regular medical care. |
Timeline
- Start date
- 2023-07-03
- Primary completion
- 2025-10-06
- Completion
- 2025-10-06
- First posted
- 2023-08-14
- Last updated
- 2025-11-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05985291. Inclusion in this directory is not an endorsement.