Ultrasound-guided ulnar nerve PCR test to diagnose and monitor leprosy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective cohort uses ultrasound to guide a perineural subcutaneous aspirate of the ulnar nerve and applies PCR (including RLEP and 16S targets) to detect M. leprae DNA and RNA. Researchers will combine clinical exam, nerve ultrasound findings, and molecular results to measure diagnostic accuracy and potential markers of bacterial viability for treatment monitoring. Participants are people aged 14 and older with clinical suspicion of leprosy or peripheral nerve enlargement and no prior leprosy treatment. The approach aims to improve detection in neural forms of leprosy where skin tests and biopsies have limited sensitivity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Individuals aged 14 years or older;

Clinical suspicion of leprosy based on dermatologic or neurologic examination OR;

Presence of peripheral nerve enlargement or skin lesions compatible with leprosy;

Ability to provide written informed consent.

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Exclusion Criteria:

Previous treatment for leprosy;

Contraindication to the aspiration procedure (e.g., coagulopathy or anticoagulant therapy);

Local infection at the puncture site;

Inability or unwillingness to provide informed consent.

Where it's running

• University Hospital of Brasília
  Brasília, Federal District, Brazil Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.