Efficacy and host-pathogen response of heat treatment in patients with Buruli ulcer (BU) using a Phase Change Material (PCM) device

Phase 2

Completed

• Conditions: Buruli ulcer (BU); Infections and Infestations; Infection due to other mycobacteria

• Registration Number: ISRCTN72102977
• Lead Sponsor: niversity Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-27
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients (both males and females, age equal or greater than 4 years) with ulcers clinically diagnosed as BU (WHO 2001)

Exclusion Criteria

1. Patients with significant other communicable and non-communicable diseases:
1.1. Clinical signs and symptoms of significant communicable diseases other than BU (fever, weight loss, night sweats, persistent cough, jaundice, pulmonary or myocardial dysfunction, central nervous system [CNS] involvement, ascites, pleural effusion)
1.2. Clinical signs and symptoms of significant non-communicable diseases (myocardial, pulmonary, renal, CNS)
2. Patients on chemotherapy for BU (streptomycin, rifampicin)

Study & Design

• Study Type: Interventional
• Study Design: Not specified