Contact information
Type
Scientific
Primary contact
Dr Thomas Junghanss
ORCID ID
Contact details
Section of Clinical Tropical Medicine
University Hospital Heidelberg
INF 324
Heidelberg
69120
Germany
Thomas.Junghanss@urz.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Phase change material to treat Buruli ulcer through heat treatment: a prospective observational single centre proof-of-principle study
Acronym
Study hypothesis
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
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
Study design
Prospective observational single-centre study (proof-of-principle study)
Primary study design
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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 outcome measures
Histopathological changes in response to thermotherapy on day 28.
Overall trial start date
28/02/2007
Overall trial end date
27/02/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
10
Participant 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.
Recruitment start date
28/02/2007
Recruitment end date
27/02/2009
Locations
Countries of recruitment
Cameroon
Trial participating centre
Section of Clinical Tropical Medicine
Heidelberg
69120
Germany
Sponsor information
Organisation
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Sponsor details
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Volkswagen Foundation (VolkswagenStiftung) (Germany) (ref: I/81 308)
Alternative name(s)
VolkswagenStiftung
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19221594
Publication citations
-
Results
Junghanss T, Um Boock A, Vogel M, Schuette D, Weinlaeder H, Pluschke G, Phase change material for thermotherapy of Buruli ulcer: a prospective observational single centre proof-of-principle trial., PLoS Negl Trop Dis, 2009, 3, 2, e380, doi: 10.1371/journal.pntd.0000380.