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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