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 Buruli ulcer and the surrounding tissue of the patient. Due to the properties of the bandage patients can mov
Sponsors
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients (male and female) aged 6 - 21 years 2. Single ulcer clinically diagnosed as Buruli ulcer (WHO 2001) 3. Laboratory confirmation of Buruli ulcer: on day 0 four swabs from the undermined edges and one diagnostic biopsy from all patients enrolled into the trial on clinical grounds are taken. All samples are investigated by microscopy for acid-fast bacilli (AFB) after Ziehl Neelsen (ZN) staining and by IS2404 real-time polymerase chain reaction (PCR). Histopathological changes typical for BU are recorded.
Exclusion criteria
Exclusion criteria: In view of the unproblematic nature of the treatment no relevant adverse effects are foreseen. Nevertheless, patients with significant underlying other communicable and non-communicable diseases are excluded in this first proof-of-principle study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Small ulcers: complete healing (primary closure of ulcer) 2. Large ulcers: healing to a stage that patient can undergo skin grafting 3. Relapse rate over a follow up period of 2 years after completion of heat treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Histopathological changes in response to thermotherapy on day 28. | — |
Countries
Cameroon
Outcome results
None listed