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

Sponsor
Wah Medical college , POF hospital
Study ID
NCT07800468
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Topical Lidocaine 2% Gel — DRUG
    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).
  • Duloxetine (60 MG) — DRUG
    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).

Study Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Dec 1, 2026
Status verified
Aug 2026
Primary completion
Mar 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: Topical Lidocaine Gel
    Participants receive topical lidocaine 2% gel applied as a thin layer to the affected areas of both feet twice daily (maximum 6 g/day) for 8 consecutive weeks.
  • Active Comparator: Group B: Oral Duloxetine
    Participants receive oral duloxetine delayed-release capsules initiated at 30 mg once daily for the first 2 weeks and then escalated to 60 mg once daily for the remaining 6 weeks (total treatment duration: 8 weeks).

Primary Outcome Measure

Change in Pain Intensity Score on the Numeric Rating Scale (NRS) [ Time Frame: Baseline (Week 0) and Week 8 ]

Central Contacts

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