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Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure

RecruitingNAAges 14 Years - anyAllUniversity of Brasilia
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In plain words

What the trial is, and whether it could suit you

\*\*Brief Summary\*\* Leprosy is a chronic granulomatous infectious disease caused by \*Mycobacterium leprae\* or \*Mycobacterium lepromatosis\*, characterized by peripheral nerve involvement that may lead to progressive neurological damage, disability, and deformities if not diagnosed and treated early. The diagnosis of leprosy is primarily clinical and epidemiological, supported by laboratory methods such as bacilloscopy and biopsy; however, these tests have limited sensitivity, particularly due to the bacillus' tropism for peripheral nerve structures. Ultrasonography has emerged as a non-invasive imaging method capable of detecting morphological changes in peripheral nerves, including nerve enlargement, fascicular abnormalities, and inflammatory hypervascularization. Despite its diagnostic value, ultrasonography alone cannot detect the presence of the bacillus. This prospective coh

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📋 Eligibility rules (as published)
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. \- 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.
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What it tests

  • Ultrasound-Guided Ulnar Perineural Subcutaneous Aspirate
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Where

1 site
University Hospital of Brasília
Brasília, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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