Condition category
Infections and Infestations
Date applied
12/08/2008
Date assigned
29/08/2008
Last edited
24/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.med.uni-heidelberg.de/

Funders

Funder type

Industry

Funder name

Volkswagen Foundation (VolkswagenStiftung) (Germany) (ref: I/81 308)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19221594

Publication citations

  1. 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.

Additional files

Editorial Notes