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Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy

Study acronym: PDN-SENSORY
StatusActive, Not Recruiting
PhaseNot applicable
SponsorNevro Corp
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study completion moved earlier from Aug 31, 2026 to Jul 2026v6
  2. Primary completion date changed from estimate of Jun 30, 2025 to Mar 13, 2026v5
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 236 to confirmed 143
    • Site details revised at 2 of 2 sites
    v4
  4. Start date changed from estimate of Apr 15, 2023 to Apr 24, 2023v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date: Apr 1, 2023 to Apr 15, 2023
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Nevro Corp
6 trials monitored
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Diabetes
5,087 trials monitored
See 222 trials at risk
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.
Trial Details
NCT Number NCT05777317
Lead Sponsor Nevro Corp
Conditions
(from sponsor)		 Painful Diabetic Neuropathy
Related terms Diabetic Neuropathies
Enrollment 143 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov