ISRCTN ISRCTN88392614
DOI https://doi.org/10.1186/ISRCTN88392614
Secondary identifying numbers N/A
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

Section of Clinical Tropical Medicine
University Hospital Heidelberg
INF 324
Heidelberg
69120
Germany

Email Thomas.Junghanss@urz.uni-heidelberg.de

Study information

Study designProspective observational single-centre study (proof-of-principle study)
Primary study designObservational
Secondary study designOther
Study setting(s)Hospital
Study typeTreatment
Scientific titlePhase change material to treat Buruli ulcer through heat treatment: a prospective observational single centre proof-of-principle study
Study objectivesBuruli 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) studiedBuruli ulcer (BU)
InterventionPhase 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 typeOther
Primary outcome measure1. 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 outcome measuresHistopathological changes in response to thermotherapy on day 28.
Overall study start date28/02/2007
Completion date27/02/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants10
Key inclusion criteria1. 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 criteriaIn 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 enrolment28/02/2007
Date of final enrolment27/02/2009

Locations

Countries of recruitment

  • Cameroon
  • Germany

Study participating centre

Section of Clinical Tropical Medicine
Heidelberg
69120
Germany

Sponsor information

University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Hospital/treatment centre

Im Neuenheimer Feld 672
Heidelberg
69120
Germany

Website http://www.med.uni-heidelberg.de/
ROR logo "ROR" https://ror.org/013czdx64

Funders

Funder type

Industry

Volkswagen Foundation (VolkswagenStiftung) (Germany) (ref: I/81 308)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
VolkswagenStiftung
Location
Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2009 Yes No