Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07800468 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Efficacy of Topical Lidocaine Gel vs. Oral Duloxetine for Painful Diabetic Peripheral Neuropathy

StatusNot Yet Recruiting
PhasePhase 4
Started2026-12-01
View on ClinicalTrials.gov ↗
The goal of this clinical trial is to learn if topical lidocaine gel can effectively reduce pain intensity compared to oral duloxetine in adult patients (aged 30-70 years) with type 2 diabetes suffering from painful diabetic peripheral neuropathy. The main questions it aims to answer are: Is there a significant difference in the reduction of pain intensity (measured by the Numeric Rating Scale) between topical lidocaine 2% gel and oral duloxetine after 8 weeks of treatment? How does the safety and tolerability profile of topical lidocaine gel compare with oral duloxetine in this patient population? Researchers will compare Group A (Topical Lidocaine 2% gel applied to the affected areas of both feet twice daily) to Group B (Oral Duloxetine 60 mg taken once daily) to see if topical lidocaine provides comparable pain relief to oral duloxetine with a reduction in systemic adverse drug reactions. Participants will: Complete a baseline clinical assessment, including nerve pain evaluation using the DN4 questionnaire and rating their pain severity on the Numeric Rating Scale (NRS). Be randomly assigned to receive either topical lidocaine 2% gel applied twice daily to both feet or oral duloxetine capsules (30 mg once daily for 2 weeks, then escalated to 60 mg once daily) for 8 consecutive weeks. Maintain their existing routine antidiabetic medications throughout the study. Attend an interim safety check visit at Week 4 to report and document any side effects or adverse drug reactions. Attend a final evaluation visit at Week 8 to record their post-treatment NRS pain score and complete safety reporting.
Trial Details
NCT Number NCT07800468
Lead Sponsor Wah Medical college , POF hospital
Conditions Painful Diabetic Neuropathy (PDN), Diabetic Neuropathies, Type 2 Diabetes
Enrollment 80 participants
Start Date 2026-12-01
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-02