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Can a numbing gel on the feet beat a daily pill for diabetic nerve pain?

NCT ID NCT07800468

Symptom relief Sponsor: Wah Medical college , POF hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether a lidocaine gel applied to the feet can ease painful diabetic neuropathy as well as the oral drug duloxetine. Adults with type 2 diabetes and moderate-to-severe nerve pain will be randomly assigned to one of the two treatments for 8 weeks. Researchers will measure changes in pain scores and track side effects to see if the topical gel offers a safer, targeted alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Topical lidocaine 2% gel and oral duloxetine
What this could lead to
If topical lidocaine works as well as duloxetine, people with diabetic nerve pain might get a targeted option with fewer whole-body side effects.
What could go wrong
This is a small, 8-week trial, so results may not apply broadly. Lidocaine may not match duloxetine's pain relief, and both treatments carry risks like skin irritation or nausea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy neuralgia type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic neuropathies Painful diabetic neuropathy (PDN) Type 2 diabetes

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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