Buruli ulcer (BU) Infections and Infestations Infection due to other mycobacteria
Conditions
Interventions
Phase change material as heat delivery system as part of a bandage which is applied to the BU and the surrounding tissue of the patient. Due to the properties of the bandage patients can move around f
Sponsors
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (both males and females, age equal or greater than 4 years) with ulcers clinically diagnosed as BU (WHO 2001)
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients cured 6 months after completing heat treatment. Cure is defined as complete closure of the wound by epithelialisation or scarification or by skin graft. 2. Proportion of patients recurrence free 12 and 24 months after completing heat treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients who were not withdrawn for low compliance or who did not withdraw consent after starting the heat treatment 2. Proportion of patients with adverse events (AEs) being at least considered as possibly related to the heat treatment 3. Proportion of patients showing diminishment of bacterial burden in microbiological assessments of punch biopsies and swabs (i.e. reduction of bacterial counts and changes in bacterial morphology in microscopy and in the quantity of M. ulcerans DNA/RNA in polymerase chain reaction [PCR]) at day 14 and day 28 (punch biopsies) or days 7, 14 and 28 (swabs) after start of treatment compared to reference samples at day 0 4. Proportion of patients showing qualitatively histopathological signs for infiltration and tissue repair at day 14 and day 28 after start of treatment compared to reference sample at day 0 5. Proportion of patients showing increases in immunological response parameters at day 14 and day 28 after start of treatment compared to reference sample at day 0 | — |
Countries
Cameroon
Outcome results
None listed