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

NCT07800468 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-09-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Topical Lidocaine 2% Gel

Applied topically to intact skin of affected areas on both feet twice daily for 8 weeks (1-2 g per foot per application; not exceeding 6 g/day total).

DRUG

Duloxetine (60 MG)

Administered orally as a delayed-release capsule: 30 mg once daily for 2 weeks, then increased to 60 mg once daily for 6 weeks (total 8 weeks).

Sponsors & Collaborators

  • Wah Medical college , POF hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2027-03-01
Completion
2027-04-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07800468 on ClinicalTrials.gov