Condition category
Infections and Infestations
Date applied
12/02/2009
Date assigned
27/02/2009
Last edited
14/01/2016
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

A Phase II non-comparative, open label, single-centre study to evaluate the efficacy and host-pathogen response of heat treatment in patients with Buruli ulcer (BU) using a Phase Change Material (PCM) device

Acronym

BU-HEAT-Rx

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 and successfully tested in a proof-of-principle-trial (ISRCTN88392614) a heat delivery device which is easy to apply, rechargeable in hot water, non-toxic and non-hazardous to the environment.

Please note that as of 25/11/2009 this trial record has been updated. All updates may be found in the relevant field with the above update date.

Ethics approval

1. Cameroon: National Ethics Committee (Comite National D'Ethique), 30/12/2008
2. Germany: Ethics Committee of the Medical Faculty Heidelberg (Ethikkommission der Medizinischen Fakultaet Heidelberg), 28/01/2009, ref: S-424/2008

Study design

Interventional open-label single-arm single-centre trial

Primary study design

Interventional

Secondary study design

Other

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a 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 BU 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 ulcers and without significant oedema) and 6 weeks (large ulcers and/or significant oedema). Total duration of follow-up: 2 years.

Added 25/11/2009:
17 patients have received treatment starting on 20/02/2009 and are now in the follow up period
Along with the original cohort of 17, 5 more cohorts of 16 +/- 2 will be treated over the next 3 years.

Intervention type

Device

Phase

Phase II

Drug names

Primary outcome measures

1. Proportion of patients cured 6 months after completing heat treatment. Cure is defined as complete closure of the wound by epithelialisation or scarification or by skin graft.
2. Proportion of patients recurrence free 12 and 24 months after completing heat treatment

Secondary outcome measures

1. Proportion of patients who were not withdrawn for low compliance or who did not withdraw consent after starting the heat treatment
2. Proportion of patients with adverse events (AEs) being at least considered as possibly related to the heat treatment
3. Proportion of patients showing diminishment of bacterial burden in microbiological assessments of punch biopsies and swabs (i.e. reduction of bacterial counts and changes in bacterial morphology in microscopy and in the quantity of M. ulcerans DNA/RNA in polymerase chain reaction [PCR]) at day 14 and day 28 (punch biopsies) or days 7, 14 and 28 (swabs) after start of treatment compared to reference samples at day 0
4. Proportion of patients showing qualitatively histopathological signs for infiltration and tissue repair at day 14 and day 28 after start of treatment compared to reference sample at day 0
5. Proportion of patients showing increases in immunological response parameters at day 14 and day 28 after start of treatment compared to reference sample at day 0

Overall trial start date

20/02/2009

Overall trial end date

20/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (both males and females, age equal or greater than 4 years) with ulcers clinically diagnosed as BU (WHO 2001)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Added 25/11/2009: 100 (6 cohorts of 16 +/- 2)

Participant exclusion criteria

1. Patients with significant other communicable and non-communicable diseases:
1.1. Clinical signs and symptoms of significant communicable diseases other than BU (fever, weight loss, night sweats, persistent cough, jaundice, pulmonary or myocardial dysfunction, central nervous system [CNS] involvement, ascites, pleural effusion)
1.2. Clinical signs and symptoms of significant non-communicable diseases (myocardial, pulmonary, renal, CNS)
2. Patients on chemotherapy for BU (streptomycin, rifampicin)

Recruitment start date

20/02/2009

Recruitment end date

20/05/2011

Locations

Countries of recruitment

Cameroon

Trial participating centre

University Hospital Heidelberg
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

Other

Funder name

Volkswagen Foundation (VolkswagenStiftung) (Germany) (ref: I/83 232)

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

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26486698
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26486698

Publication citations

Additional files

Editorial Notes

14/01/2016: Publication reference added.