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

NCT ID
NCT07800468
Registry status
Not yet recruiting
Study type
Not specified in the registry data
Phase
Phase 4
Sponsor
Wah Medical college , POF hospital

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 80 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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)

Study locations

No study locations are listed in the registry data.

Study details

Start date
December 1, 2026
Primary completion date
March 1, 2027
First posted
September 2, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07800468
Registry last updated
September 2, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07800468 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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