RecruitingNCT06495424

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

A Post-Market Observational Multi-Center Study to Evaluate the Effectiveness of Repeated QUTENZA Use in Adults With Painful Diabetic Peripheral Neuropathy of the Feet

Sponsor

Averitas Pharma, Inc.

Enrollment

150 participants

Start Date

Mar 14, 2025

Study Type

OBSERVATIONAL

Conditions

Peripheral Diabetic Neuropathy Painful Diabetic Neuropathy

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking how well a high-concentration capsaicin skin patch (QUTENZA) works over time in people with painful diabetic nerve damage (diabetic peripheral neuropathy). **You may be eligible if...** - You are 18–80 years old - You have been diagnosed with painful diabetic peripheral neuropathy confirmed by a standard questionnaire (DN4 score of 3 or more out of 7) - Your pain level is at least 4 out of 10 in the week before starting the study - Your doctor has already decided to treat you with QUTENZA patches **You may NOT be eligible if...** - You have a different cause of nerve pain (not diabetic) - You have severe wounds, infections, or skin conditions on the affected area - You are pregnant or breastfeeding - You are enrolled in another interventional trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCapsaicin 8%

Repeat applications every 12 weeks in patients with PDPN of the feet.

Locations(14)

Pacific Research Institute

Lakeport, California, United States

Pacific Research Institute

Santa Rosa, California, United States

Pacific Research Institute

Santa Rosa, California, United States

Pacific Research Institute

Sonoma, California, United States

Center for Interventional Pain and Spine

Wilmington, Delaware, United States

Horizon Clinical Research

Gainesville, Georgia, United States

Horizon Clinical Research

Jasper, Georgia, United States

Horizon Clinical Research

Newnan, Georgia, United States

Iqra Research

Edgewood, Kentucky, United States

Curalta Clinical Trials

Oradell, New Jersey, United States

Iqra Research

Cincinnati, Ohio, United States

Center for Interventional Pain and Spine

Bryn Mawr, Pennsylvania, United States

Center for Interventional Pain and Spine

Fort Washington, Pennsylvania, United States

Center for Interventional Pain and Spine

Lancaster, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06495424

Related Trials

SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease

NCT064807861 location

Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy

NCT046788951 location

The Association Between Cognitive Function and Neuropathy in Individuals With Type 2 Diabetes

NCT068579941 location

Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

NCT046997341 location