Actively Recruiting
Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure
Led by University of Brasilia · Updated on 2026-04-07
108
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Leprosy is a chronic infectious disease caused by Mycobacterium leprae or Mycobacterium lepromatosis, mainly affecting the peripheral nerves and leading to neurological damage, disability, and deformities if not diagnosed and treated early. This research evaluates the diagnostic and prognostic accuracy of combining clinical evaluation, peripheral nerve ultrasonography, and molecular detection techniques using ultrasound-guided perineural subcutaneous aspirate. The goal is to improve early detection and monitoring of leprosy compared with traditional methods like bacilloscopy and biopsy. Participants with suspected leprosy will undergo clinical exams, high-resolution ultrasound of the ulnar nerves, and an ultrasound-guided subcutaneous aspirate near the nerve. This aspirate is tested using real-time PCR and RT-PCR to detect DNA and RNA of Mycobacterium leprae, which may help identify viable bacteria. The study involves assessments at diagnosis and after one year of treatment to compare findings and evaluate the new diagnostic method's accuracy. Throughout the one-year study, participants will have clinical and imaging evaluations, molecular testing of aspirated material, and monitoring of nerve changes. Researchers will measure the diagnostic accuracy of the molecular tests and correlate ultrasound findings with molecular results. This approach aims to develop improved, less invasive diagnostic workflows that can be used in public health settings to reduce disease transmission and long-term disability.
CONDITIONS
Brief Title
Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Previous treatment for leprosy
- Contraindication to the aspiration procedure such as coagulopathy or anticoagulant therapy
- Local infection at the puncture site
- Inability or unwillingness to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo clinical evaluation, peripheral nerve ultrasound, and an ultrasound-guided ulnar perineural subcutaneous aspirate for molecular testing to detect Mycobacterium leprae DNA and RNA.
1 visit (in-person)
Duration - About 1 year after diagnostic evaluation
Participants are evaluated approximately one year after treatment to assess disease status and treatment effectiveness using clinical and molecular methods.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
University Hospital of Brasília
Brasília, Federal District, Brazil, 70.830-200
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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