Heat treatment of Buruli ulcer
| ISRCTN | ISRCTN88392614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88392614 |
| Protocol serial number | N/A |
| Sponsor | University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany) |
| Funder | Volkswagen Foundation (VolkswagenStiftung) (Germany) (ref: I/81 308) |
- Submission date
- 12/08/2008
- Registration date
- 29/08/2008
- Last edited
- 24/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Thomas Junghanss
Scientific
Scientific
Section of Clinical Tropical Medicine
University Hospital Heidelberg
INF 324
Heidelberg
69120
Germany
| Thomas.Junghanss@urz.uni-heidelberg.de |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational single-centre study (proof-of-principle study) |
| Secondary study design | Other |
| Scientific title | Phase change material to treat Buruli ulcer through heat treatment: a prospective observational single centre proof-of-principle study |
| Study objectives | Buruli ulcer (BU) is a chronic necrotising disease of skin and soft tissue caused by Mycobacterium ulcerans. BU has been reported in more than 30 countries, but the major burden lies on children living in remote areas of West Africa associated with swamps and stagnant water bodies. Heat has been shown to be effective in the treatment of BU in the early 70's. Based on these results, World Health Organization (WHO) guidelines listed the application of heat as a treatment option for BU. However, the heat application devices employed so far were impractical in most endemic countries. We developed a heat delivery device which is easy to apply, rechargeable in hot water, non-toxic and non-hazardous to the environment. |
| Ethics approval(s) | Ethics approval received from: 1. Ethics Committee of the Medical Faculty Heidelberg (Ethikkommission der Medizinischen Fakultät Heidelberg [Germany]) on the 6th March 2006 (ref: 490/2005) 2. National Ethics Committee (Comite National D'Ethique [Cameroon]) on the 21st August 2006 |
| Health condition(s) or problem(s) studied | Buruli ulcer (BU) |
| Intervention | 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 move around freely during treatment. Duration of heat treatment: 4 weeks (small ulcres and without significant oedema) and 6 weeks (large ulcers and/or significant oedema). Total duration of follow-up: 2 years. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Small ulcers: complete healing (primary closure of ulcer) |
| Key secondary outcome measure(s) |
Histopathological changes in response to thermotherapy on day 28. |
| Completion date | 27/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 10 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 28/02/2007 |
| Date of final enrolment | 27/02/2009 |
Locations
Countries of recruitment
- Cameroon
- Germany
Study participating centre
Section of Clinical Tropical Medicine
Heidelberg
69120
Germany
69120
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2009 | Yes | No |
