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NCT05985291 · ClinicalTrials.gov registry record
BurstDR Stimulation for Painful Diabetic Neuropathy
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- 6
- Enrollment target
NCT05985291: Clinical Trial study, sponsored by Wake Forest University Health Sciences.
NCT05985291 is a clinical trial that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05985291 was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- 6 participants
- Enrollment target
Study 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.
Primary Outcome
Responder is defined as a subject who has at least 50% reduction in lower limb pain from baseline as measured by a 10 cm Visual Analog Scale (VAS).
Interventions
- COMBINATION_PRODUCT SCS in combination with CMM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-07-03 |
| Est. Completion | 2025-10-06 |
Why NCT05985291 stopped before completion
NCT05985291 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 6 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which SCS in combination with CMM is the first listed.
NCT05985291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05985291 about?
NCT05985291 is a clinical study titled "BurstDR Stimulation for Painful Diabetic Neuropathy". 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.
What is the current status of trial NCT05985291?
This trial is currently terminated. The enrollment target is 6 participants. The study started on 2023-07-03. Estimated completion is 2025-10-06.
What interventions are being tested in trial NCT05985291?
The interventions under investigation include: SCS in combination with CMM (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05985291?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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