NCT07800468Not yet recruitingPhase 4
Efficacy of Topical Lidocaine Gel vs. Oral Duloxetine for Painful Diabetic Peripheral Neuropathy
Comparison of the Efficacy of Topical Lidocaine Gel Versus Oral Duloxetine in the Treatment of Painful Diabetic Peripheral Neuropathy: A Prospective Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 28 Aug 2026
- Start date
- Dec 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Wah Medical college , POF hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07800468
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 80
- From Dec 2026 to the primary completion date, Mar 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of other neuropathic pain medications (gabapentinoids, tricyclic antidepressants, opioids, or topical capsaicin) within 4 weeks of enrollment
Other illness
- Known hypersensitivity or contraindication to lidocaine or duloxetine
- Active skin lesions, open wounds, or dermatological conditions at the intended application site on the feet
- Other causes of peripheral neuropathy (e.g., alcohol-related, hypothyroidism, vitamin B12 deficiency, or Charcot-Marie-Tooth disease)
Lab values
- Significant hepatic impairment (ALT or AST \> 3 times the upper limit of normal)
- Severe renal impairment (eGFR \< 30 mL/min/1.73 m²)
Other
- Pregnant or lactating females
Who the study is looking for
- Adult patients aged 30 to 70 years
- Confirmed type 2 diabetes mellitus (as per WHO 2019 criteria) for at least 1 year
- HbA1c \< or = 10% (or documented stable glycemic control over the preceding 3 months)
- Diagnosis of painful diabetic peripheral neuropathy (PDPN) with a DN4 score \> or = 4/10
- Baseline Numeric Rating Scale (NRS) pain score \>= 4/10 (moderate-to-severe pain)
- Willing and able to provide written informed consent
Age in the registry: 30 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.