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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Section of Clinical Tropical Medicine
University Hospital Heidelberg
INF 324
Heidelberg
69120
Germany
| thomas.junghanss@urz.uni-heidelberg.de |
Study information
| Study design | Interventional open-label single-arm single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Other |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 20/02/2009 |
| Completion date | 20/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Sex | Both |
| Target number of participants | Added 25/11/2009: 100 (6 cohorts of 16 +/- 2) |
| 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
69120
Germany
Sponsor information
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
| Website | http://www.med.uni-heidelberg.de/ |
|---|---|
"ROR" |
https://ror.org/013czdx64 |
Funders
Funder type
Other
Volkswagen Foundation (VolkswagenStiftung) (Germany) (ref: I/83 232)
Private sector organisation / Trusts, charities, foundations (both public and private)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2016 | Yes | No | |
| Results article | results | 01/02/2016 | Yes | No |
Editorial Notes
14/01/2016: Publication reference added.
