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RECRUITING

Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Peripheral Neuropathy

NCT06495424 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this post-market observational study is to provide real-world evidence to support the repeated use of QUTENZA in patients with PDPN and to evaluate the potential for pain and concomitant medication use reduction.

Interventions

  • DRUG Capsaicin 8%

Study Locations (14)

California

  • Pacific Research Institute — Lakeport
  • Pacific Research Institute — Santa Rosa
  • Pacific Research Institute — Santa Rosa
  • Pacific Research Institute — Sonoma

Georgia

  • Horizon Clinical Research — Gainesville
  • Horizon Clinical Research — Jasper
  • Horizon Clinical Research — Newnan

Pennsylvania

  • Center for Interventional Pain and Spine — Bryn Mawr
  • Center for Interventional Pain and Spine — Fort Washington
  • Center for Interventional Pain and Spine — Lancaster

Delaware

  • Center for Interventional Pain and Spine — Wilmington

Kentucky

  • Iqra Research — Edgewood

New Jersey

  • Curalta Clinical Trials — Oradell

Ohio

  • Iqra Research — Cincinnati

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2025-03-14
Est. Completion 2027-03

Sponsor

Averitas Pharma

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06495424

The ClinicalTrials.gov registry entry for NCT06495424 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Averitas Pharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Painful Diabetic Neuropathy appearing as the primary indexed condition, and to 1 intervention — of which Capsaicin 8% 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: NCT06495424 reports 14 study locations spanning 7 distinct geographic areas — top geographies include California, Georgia, Pennsylvania. 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 NCT06495424 about?

NCT06495424 is a clinical study titled "Observational Study to Evaluate the Efficacy of Sustained QUTENZA® Use in Painful Diabetic Peripheral Neuropathy". The purpose of this post-market observational study is to provide real-world evidence to support the repeated use of QUTENZA in patients with PDPN and to evaluate the potential for pain and concomitant medication use reduction.

What is the current status of trial NCT06495424?

This trial is currently recruiting. The enrollment target is 150 participants. The study started on 2025-03-14. Estimated completion is 2027-03.

What conditions does trial NCT06495424 study?

This clinical trial studies the following conditions: Painful Diabetic Neuropathy, Peripheral 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 NCT06495424?

The interventions under investigation include: Capsaicin 8% (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06495424?

This trial is sponsored by Averitas Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06495424 being conducted?

This trial has 14 study locations across California, Delaware, Georgia, Kentucky, New Jersey. 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