Thermotherapy of Buruli Ulcer at Community Level in the Health District of Akonolinga

Study Overview
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Brief Summary
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The project rolls out combined innovative low-tech thermotherapy of Buruli ulcer (BU) with heat packs and WHO recommended wound management in a BU endemic district of Cameroon.

Detailed Description
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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. Main objective: To determine in patients with early BU lesions the effectiveness and acceptability of thermotherapy treatment at health post and community level. Specific objectives: 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

Official Title
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Thermotherapy of Buruli Ulcer at Community Level in the Health District of Akonolinga

Conditions
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Buruli Ulcer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically diagnosed BU patients with a single WHO category I and II lesion Exclusion Criteria: - inappropriate lesion size (category III patients), location and patients with multiple lesions

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thermo<br>Buruli ulcer patients receiving thermotherapy | |
| Chemo<br>Buruli ulcer patients receiving chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary cure: wound closure and/or no BU features according to WHO guideline | 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 | 6 months | 
| Definite cure: No recurrence | Number of patients with no BU recurrence for 12 months after completion of heat treatment | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | Rates of withdrawal (due to low compliance or consent withdrawal) | 2 years | 
| Acceptability | Rating of thermotherapy by health staff | 2 years |