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

NCT07800468 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: POFH/ 05-2026/ МЕD/11
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Painful Diabetic Neuropathy (PDN); Diabetic Neuropathies; Type 2 Diabetes

Keywords

Topical Lidocaine Gel; Duloxetine; Neuropathic Pain; Diabetic Peripheral Neuropathy; Numeric Rating Scale (NRS); DN4 Questionnaire; Analgesics

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Score on the Numeric Rating Scale (NRS)

  Measured on an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Participants rate their average pain over the preceding 24 hours. Change is calculated as Week 8 score minus Baseline (Week 0) score.

  Baseline (Week 0) and Week 8

Secondary Outcomes (2)

• Incidence and Severity of Adverse Drug Reactions

  Week 4 and Week 8

• Use of Rescue Paracetamol

  Up to 8 weeks

Study Arms (2)

Group A: Topical Lidocaine Gel

EXPERIMENTAL

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.

Drug: Topical Lidocaine 2% Gel

Group B: Oral Duloxetine

ACTIVE COMPARATOR

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).

Drug: Duloxetine (60 MG)

Interventions

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).

Also known as: Duloxetine hydrochloride

Group B: Oral Duloxetine

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).

Also known as: Lidocaine gel, Topical Lidocaine

Group A: Topical Lidocaine Gel

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known hypersensitivity or contraindication to lidocaine or duloxetine
• Current use of other neuropathic pain medications (gabapentinoids, tricyclic antidepressants, opioids, or topical capsaicin) within 4 weeks of enrollment
• Significant hepatic impairment (ALT or AST \> 3 times the upper limit of normal)
• Severe renal impairment (eGFR \< 30 mL/min/1.73 m²)
• Active skin lesions, open wounds, or dermatological conditions at the intended application site on the feet
• Pregnant or lactating females
• Other causes of peripheral neuropathy (e.g., alcohol-related, hypothyroidism, vitamin B12 deficiency, or Charcot-Marie-Tooth disease)

Sponsors & Collaborators

• Wah Medical college , POF hospital: lead

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus, Type 2; Neuralgia

Interventions

Lidocaine; Gels; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Muhammad Ali Javed, MBBS

CONTACT

03295718202; ajaved123886@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participant and investigator blinding is open-label due to different administration routes; primary outcome assessors measuring NRS scores are blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, open-label, parallel-group, randomized controlled trial comparing topical lidocaine 2% gel applied twice daily with oral duloxetine (60 mg daily) over an 8-week treatment period in two parallel arms.

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08