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NCT05777317 · ClinicalTrials.gov registry record · NA
Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy
A NA study of Painful Diabetic Neuropathy, sponsored by Nevro.
- Active
- Registry status
- NA
- Development phase
- 143
- Enrollment target
- 2
- Study locations
NCT05777317: Active NA study of Painful Diabetic Neuropathy, sponsored by Nevro.
NCT05777317 is a NA study of Painful Diabetic Neuropathy that is active but no longer recruiting, run by Nevro. The registered enrollment target is 143 participants, above the 104-participant average among 5 other Painful Diabetic Neuropathy trials with a reported enrollment target (38% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05777317, a NA study of Painful Diabetic Neuropathy, is active but no longer recruiting, sponsored by Nevro.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 143 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated with diabetic peripheral neuropathy, a condition known as painful diabetic neuropathy (PDN). This is a multi-center, prospective, randomized controlled study to evaluate improvement in pain and neurological function in PDN patients, with neurological function assessed via objective measures. Patients will be randomized to conventional medical management (CMM) or 10 kHz SCS plus CMM.
Primary Outcome
The lower limb pain responder rate is the proportion of subjects who are pain responders, where a responder is defined as having at least 50% reduction in average lower limb pain score from baseline as measured on a 10-cm Visual Analog Scale (VAS, where a higher score indicates greater pain.
Conditions Studied
Interventions
- DEVICE 10 kHz SCS
- OTHER CMM alone
Study Locations (2)
North Carolina
- Atrium Health Wake Forest Baptist - Winston-Salem
Oregon
- Touchstone Interventional Pain Center - Medford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2023-04-24 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
What the registry record for NCT05777317 still lists
NCT05777317 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, above the 104-participant average among 5 other Painful Diabetic Neuropathy trials with a reported enrollment target (38% higher).
The record links to 1 condition, with Painful Diabetic Neuropathy appearing as the primary indexed condition, and to 2 interventions - of which 10 kHz SCS is the first listed.
NCT05777317 reports a single indexed study location in North Carolina, Oregon.
Frequently Asked Questions
What is clinical trial NCT05777317 about?
NCT05777317 is a clinical study titled "Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy". The purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated with diabetic peripheral neuropathy, a condition known as painful diabetic...
What is the current status of trial NCT05777317?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 143 participants. The study started on 2023-04-24. Estimated completion is 2026-08-31.
What conditions does trial NCT05777317 study?
This clinical trial studies the following conditions: Painful Diabetic Neuropathy.
What interventions are being tested in trial NCT05777317?
The interventions under investigation include: 10 kHz SCS (DEVICE), CMM alone (OTHER).
Who is sponsoring clinical trial NCT05777317?
This trial is sponsored by Nevro, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05777317 being conducted?
This trial has 2 study locations across North Carolina, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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