Thermotherapy of Buruli Ulcer at Community Level in the Health District of Akonolinga (UB Thermo)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03969940|
Recruitment Status : Withdrawn (Lack of supply of comparator drug in country)
First Posted : May 31, 2019
Last Update Posted : December 21, 2020
|Condition or disease|
The project translates available clinical research findings at the secondary health care level into clinical practice at the primary health care and community level. The string of previous work from the development of the BU thermotherapy-wound management-package to the proof of its efficacy provides all necessary procedures, tools and documents to immediately proceed into practical and integrated community application.
To determine in patients with early BU lesions the effectiveness and acceptability of thermotherapy treatment at health post and community level.
- To monitor and evaluate clinical and biological responses to thermotherapy in patients receiving up to 8 weeks of thermotherapy
- To assess within 6 months after completion of heat treatment wound closure ("primary cure") and/or absence of BU specific features in included patients according to WHO healing criteria
- To measure the BU recurrence rate in included patient within 12 months after completion of heat treatment' ("definite cure").
- To assess the compliance rate of included patients
- To assess the withdrawal rate of included patients
- To assess the ability and comfort of health personnel to use the thermotherapy device
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Thermotherapy of Buruli Ulcer at Community Level in the Health District of Akonolinga|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Buruli ulcer patients receiving thermotherapy
Buruli ulcer patients receiving chemotherapy
- Primary cure: wound closure and/or no BU features according to WHO guideline [ Time Frame: 6 months ]Number of patients with wound closure and/or absence of clinically BU specific features according to WHO guidelines within 6 months after completion of heat treatment
- Definite cure: No recurrence [ Time Frame: 12 months ]Number of patients with no BU recurrence for 12 months after completion of heat treatment
- Acceptability [ Time Frame: 2 years ]Rates of withdrawal (due to low compliance or consent withdrawal)
- Acceptability [ Time Frame: 2 years ]Rating of thermotherapy by health staff
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969940
|Study Chair:||Thomas Junghanss, MD||University Hospital Heidelberg|