Evaluating Ultrasound-Guided PCR Testing of Ulnar Nerve Aspirate for Diagnosing and Monitoring Leprosy

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 methods 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.

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