The project rolls out combined innovative low-tech thermotherapy with heat packs and WHO recommended wound management in a Buruli ulcer (BU)-endemic district of West Africa. It addresses three key areas of considerable clinical and public health importance in the region:
Operational endpoints are
The project is embedded into a stable multidisciplinary working environment at Côte d'Ivoire, including an HDSS with a longstanding record of partnership and successful community-based operational research.
The project builds on the principles laid out by the Sustainable Development Goals (SDGs) and Universal Health Coverage (UHC) and
Condition or disease | Intervention/treatment |
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Skin Ulcer Buruli Ulcer Nontuberculous Mycobacteria | Other: thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemia |
Overall goal of the study To contribute to a better understanding of the clinical epidemiology of wounds and wound healing and to improve wound management in settings with limited resources at the community level, the primary and secondary level of the health care services.
Study objectives Main study
To measure the effectiveness and acceptability of thermotherapy of patients with early BU (< 2cm) treated at health post level with the following outcomes:
Target Population The target population are approximately 43,000 people of the Taabo HDSS which is surveyed longitudinally for key demographic, health and socioeconomic indicators since 2008. This provides ideal conditions to implement the intervention and assess the impact through operational endpoints. The health centres and the district hospital involved are part of the public health system. There is one district hospital and the seven health posts within the Taabo DHSS.
Study Type : | Observational |
Estimated Enrollment : | 5000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Treat Early and Broad: Thermotherapy of Buruli Ulcer Integrated Into WHOrecommended Wound Management in West Africa |
Actual Study Start Date : | May 7, 2019 |
Estimated Primary Completion Date : | July 1, 2024 |
Estimated Study Completion Date : | July 1, 2024 |
Group/Cohort | Intervention/treatment |
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patients exhibiting skin wounds
Within the framework of Taabo HDSS Cross-sectional community and health services surveys are performed before wound management intervention (main study and substudy 1) is implemented (baseline) and are continued at 6 monthly intervals thereafter. Surveys are done door-to-door. All patients with skin lesions (broken skin barrier) are enrolled, lesions are documented with help of a questionnaire and photographic documentation.
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patients identified in the survey and willing to participate
Each patient with a wound will be enrolled. Presumptive clinical diagnosis and empirical treatment, as well wound assessment, will be recorded at enrollment and at each follow-up visit. Additional laboratory testing done within the framework of the local health system will also be recorded.
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patients exhibiting Buruli ulcers < 2cm
Buruli ulcer patients fulfilling inclusion criteria will be offered thermotherapy instead of standard antibiotic treatment. Heat treatment is applied for 42 days plus a safety margin of up to 14 days, if ulcer margins have not fully collapsed and/or induration has not fully subsided. Treatment terminates earlier, if a lesion is completely closed. Thermotherapy will be applied with heat packs twice daily.
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Other: thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemia
Heat treatment is applied for 42 days plus a safety margin of up to 14 days, if ulcer margins have not fully collapsed and/or induration has not fully subsided. Treatment terminates earlier, if a lesion is completely closed. Thermotherapy will be applied with heat packs twice daily.
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Survey All HDSS population members Wound management study Patients with wounds defined as broken skin barrier. Thermotherapy study Buruli ulcer patients of the main study with ulcers < 2cm.
Exclusion Criteria:
none
Côte D'Ivoire | |
CSRS | |
Abidjan, Côte D'Ivoire, 1303 |
Principal Investigator: | Marija Stojkovic, MD | University Hospital Heidelberg, Germany |
Tracking Information | |||||
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First Submitted Date | May 17, 2019 | ||||
First Posted Date | May 21, 2019 | ||||
Last Update Posted Date | May 6, 2021 | ||||
Actual Study Start Date | May 7, 2019 | ||||
Estimated Primary Completion Date | July 1, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Treat Early and Broad: Thermotherapy of Buruli Ulcer Integrated Into WHOrecommended Wound Management in West Africa | ||||
Official Title | Treat Early and Broad: Thermotherapy of Buruli Ulcer Integrated Into WHOrecommended Wound Management in West Africa | ||||
Brief Summary |
The project rolls out combined innovative low-tech thermotherapy with heat packs and WHO recommended wound management in a Buruli ulcer (BU)-endemic district of West Africa. It addresses three key areas of considerable clinical and public health importance in the region:
Operational endpoints are
The project is embedded into a stable multidisciplinary working environment at Côte d'Ivoire, including an HDSS with a longstanding record of partnership and successful community-based operational research. The project builds on the principles laid out by the Sustainable Development Goals (SDGs) and Universal Health Coverage (UHC) and
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Detailed Description |
Overall goal of the study To contribute to a better understanding of the clinical epidemiology of wounds and wound healing and to improve wound management in settings with limited resources at the community level, the primary and secondary level of the health care services. Study objectives Main study
Target Population The target population are approximately 43,000 people of the Taabo HDSS which is surveyed longitudinally for key demographic, health and socioeconomic indicators since 2008. This provides ideal conditions to implement the intervention and assess the impact through operational endpoints. The health centres and the district hospital involved are part of the public health system. There is one district hospital and the seven health posts within the Taabo DHSS. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients in Taabo Health District (HDSS), Ivory Coast Survey All HDSS population members Wound management study Patients with wounds defined as broken skin barrier. Thermotherapy study Buruli ulcer patients of the main study with ulcers < 2cm. | ||||
Condition |
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Intervention | Other: thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemia
Heat treatment is applied for 42 days plus a safety margin of up to 14 days, if ulcer margins have not fully collapsed and/or induration has not fully subsided. Treatment terminates earlier, if a lesion is completely closed. Thermotherapy will be applied with heat packs twice daily.
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Estimated Enrollment |
5000 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | July 1, 2024 | ||||
Estimated Primary Completion Date | July 1, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria: Survey All HDSS population members Wound management study Patients with wounds defined as broken skin barrier. Thermotherapy study Buruli ulcer patients of the main study with ulcers < 2cm. Exclusion Criteria: none |
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Côte D'Ivoire | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03957447 | ||||
Other Study ID Numbers | WOUNDCAREV2 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Martin Koch, University Hospital Heidelberg | ||||
Study Sponsor | University Hospital Heidelberg | ||||
Collaborators | Centre Suisse de Recherches Scientifiques en Cote d'Ivoire | ||||
Investigators |
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PRS Account | University Hospital Heidelberg | ||||
Verification Date | May 2021 |