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

Withdrawn

• Conditions: Buruli Ulcer

• Registration Number: NCT03969940
• Lead Sponsor: Swiss Tropical & Public Health Institute

Brief Summary

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

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:

1. To monitor and evaluate clinical and biological responses to thermotherapy in patients receiving up to 8 weeks of thermotherapy

2. 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

3. To measure the BU recurrence rate in included patient within 12 months after completion of heat treatment' ("definite cure").

4. To assess the compliance rate of included patients

5. To assess the withdrawal rate of included patients

6. To assess the ability and comfort of health personnel to use the thermotherapy device

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-31
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary cure: wound closure and/or no BU features according to WHO guideline	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	12 months	Number of patients with no BU recurrence for 12 months after completion of heat treatment

Secondary Outcome Measures

Name	Time	Method
Acceptability	2 years	Rating of thermotherapy by health staff