Efficacy and host-pathogen response of heat treatment in patients with Buruli ulcer (BU) using a Phase Change Material (PCM) device

ISRCTN	ISRCTN72102977
DOI	https://doi.org/10.1186/ISRCTN72102977
Protocol serial number	N/A
Sponsor	University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Funder	Volkswagen Foundation (VolkswagenStiftung) (Germany) (ref: I/83 232)

Submission date: 12/02/2009
Registration date: 27/02/2009
Last edited: 14/01/2016

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

Primary study design	Interventional
Study design	Interventional open-label single-arm single-centre trial
Secondary study design	Other
Study type	Participant information sheet
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
Study acronym	BU-HEAT-Rx
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 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(s)	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
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 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 / device / biological / vaccine name(s)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	20/05/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	Patients (both males and females, age equal or greater than 4 years) with ulcers clinically diagnosed as BU (WHO 2001)
Key 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)
Date of first enrolment	20/02/2009
Date of final enrolment	20/05/2011

Locations

Countries of recruitment

Cameroon
Germany

Study participating centre

University Hospital Heidelberg

Heidelberg
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	01/02/2016		Yes	No
Results article	results	01/02/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/01/2016: Publication reference added.