NCT07515989 Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure
| NCT ID | NCT07515989 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Brasilia |
| Condition | Leprosy |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2026-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
\*\*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 cohort study aims to evaluate the diagnostic and prognostic accuracy of combining clinical evaluation, peripheral nerve ultrasonography, and molecular detection techniques using subcutaneous perineural aspirate. Patients with suspected leprosy attending the Leprosy Outpatient Clinic at the University Hospital of Brasília will undergo clinical evaluation, ultrasound examination of the ulnar nerves, and ultrasound-guided subcutaneous perineural aspirate for molecular detection of \*Mycobacterium leprae\* DNA and RNA using real-time PCR and RT-PCR. Participants will be followed for one year, with assessments performed at diagnosis and after one year of treatment. The study will compare clinical, imaging, and molecular findings to determine whether perineural subcutaneous aspirate combined with ultrasonography improves early detection and diagnostic accuracy compared with conventional methods such as bacilloscopy and biopsy. The study aims to contribute to improved diagnostic strategies for leprosy, enabling earlier detection of neural involvement and potentially reducing disease transmission and long-term disability.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07515989 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Leprosy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07515989 currently recruiting?
Yes, NCT07515989 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Brasilia to inquire about joining.
Where is the NCT07515989 trial being conducted?
This trial is being conducted at Brasília, Brazil.
Who is sponsoring the NCT07515989 clinical trial?
NCT07515989 is sponsored by University of Brasilia. The trial plans to enroll 108 participants.