Painful Diabetic Neuropathy (PDN)Phase 4NCT07800468
Efficacy of Topical Lidocaine Gel vs. Oral Duloxetine for Painful Diabetic Peripheral Neuropathy
A Phase 4 study testing Topical Lidocaine 2% Gel and Duloxetine (60 MG) in people with Painful Diabetic Neuropathy (PDN) and Diabetic Neuropathies, run by Wah Medical college , POF hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Painful Diabetic Neuropathy (PDN), Diabetic Neuropathies, Type 2 Diabetes
- What is being tested?
- Topical Lidocaine 2% Gel and Duloxetine (60 MG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Apr 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Efficacy of Topical Lidocaine Gel Versus Oral Duloxetine in the Treatment of Painful Diabetic Peripheral Neuropathy: A Prospective Randomized Controlled Trial
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?
Read more
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.
Read the detailed description
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.
- Being tested
- Topical Lidocaine 2% Gel, Duloxetine (60 MG)
- Keywords
- Topical Lidocaine Gel, Duloxetine, Neuropathic Pain, Diabetic Peripheral Neuropathy, Numeric Rating Scale (NRS), DN4 Questionnaire, Analgesics
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Type 2, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Lidocaine 2% GelDrug
Also called Lidocaine gel, Topical Lidocaine
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
Also called Duloxetine hydrochloride
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Duloxetine (60 MG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and Week 8
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic Neuropathy (PDN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wah Medical college , POF hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800468
- Sponsor's protocol ID
- POFH/ 05-2026/ МЕD/11
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No