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ACTIVE NOT RECRUITING NA

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

NCT05777317 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 143 participants
Start Date 2023-04-24
Est. Completion 2026-08-31
Phase NA

Sponsor

Nevro

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05777317

The ClinicalTrials.gov registry entry for NCT05777317 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nevro, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05777317 reports 2 study locations spanning 2 distinct geographic areas — top geographies include North Carolina, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05777317?

The interventions under investigation include: 10 kHz SCS (DEVICE), CMM alone (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05777317?

This trial is sponsored by Nevro, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial