A Phase 4 interventional study of Topical Lidocaine 2% Gel and Duloxetine (60 MG) in Painful Diabetic Neuropathy (PDN), Diabetic Neuropathies and Type 2 Diabetes, sponsored by Wah Medical college , POF hospital. Not yet recruiting. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Wah Medical college , POF hospital · Phase 4, Interventional, and Treatment
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.
Painful diabetic peripheral neuropathy (PDPN) affects up to 26% of patients with diabetes, manifesting as burning, shooting, or electric-shock-like pain primarily in the lower extremities. While systemic medications such as duloxetine, a serotonin-norepinephrine reuptake inhibitor (SNRI), are standard first-line therapies, their clinical utility is frequently constrained by systemic side effects like nausea, dizziness, and somnolence. Topical lidocaine offers a site-specific alternative by blocking voltage-gated sodium channels in peripheral nociceptors, thereby minimizing systemic drug exposure. This prospective, open-label, parallel-group, randomized controlled trial is designed to evaluate and compare the efficacy and safety of topical lidocaine 2% gel versus oral duloxetine in patients with PDPN over an 8-week treatment period. A total of 80 adult patients (30-70 years of age) with type 2 diabetes and moderate-to-severe neuropathic pain (DN4 score greater than or equal to 4/10 and baseline NRS score greater than or equal 4/10) will be recruited from the Outpatient Department of General Medicine at POF Hospital, Wah Cantt. Participants will be randomized in a 1:1 ratio into two parallel treatment arms: Group A (Intervention): Topical lidocaine 2% gel applied as a thin layer to intact skin on the affected areas of both feet twice daily (maximum 6 g/day) for 8 weeks. Group B (Control): Oral duloxetine capsules initiated at 30 mg once daily for the first 2 weeks and escalated to 60 mg once daily for the remaining 6 weeks. The primary outcome measure is the change in pain intensity from baseline (Week 0) to Week 8, evaluated using the 11-point Numeric Rating Scale (NRS). Secondary outcome measures include the incidence, nature, and severity of adverse drug reactions reported at Week 4 and Week 8, as well as the proportion of participants requiring rescue paracetamol medication. Although blinding of participants and treating physicians is not feasible due to differing routes of administration, outcome assessments will be conducted by an independent assessor blinded to treatment allocation to minimize observer bias. Data will be analyzed on an intention-to-treat basis.
538 studies on the registry are indexed under Diabetic Neuropathies; 80 are open to participants now.
This study's planned enrollment of 80 is above the median of 68 across 448 interventional studies indexed under Diabetic Neuropathies.
Browse Diabetic Neuropathies studies →Wah Medical college , POF hospital is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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
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
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.
Time frame: Baseline (Week 0) and Week 8
Incidence and Severity of Adverse Drug Reactions
Number of participants reporting adverse drug reactions (ADRs), categorized by nature and severity (mild, moderate, or severe) as documented on the study proforma.
Time frame: Week 4 and Week 8
Use of Rescue Paracetamol
Proportion of participants in each treatment group requiring paracetamol as rescue medication during the treatment period.
Time frame: Up to 8 weeks
No study locations are listed for this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
Wah Medical college , POF hospital