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

Buruli Ulcer Clinical Trial

— UB Thermo  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03969940
• Other study ID #: 2018-13
• Status: Withdrawn
• Start date: January 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2020
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Buruli Ulcer
• Ulcer

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Centre International de Recherches, d'Enseignements et de Soins, University Hospital Heidelberg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Definite cure: No recurrence	Number of patients with no BU recurrence for 12 months after completion of heat treatment	12 months
Secondary	Acceptability	Rates of withdrawal (due to low compliance or consent withdrawal)	2 years
Secondary	Acceptability	Rating of thermotherapy by health staff	2 years