Thermotherapy of Buruli Ulcer at Community Level in the Health District of Akonolinga (UB Thermo)

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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Recruitment Status : Withdrawn (Lack of supply of comparator drug in country)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

Sponsor:

Collaborators:

University Hospital Heidelberg

Centre International de Recherches, d'Enseignements et de Soins

Information provided by (Responsible Party):

Swiss Tropical & Public Health Institute

Study Description

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.

Condition or disease
Buruli Ulcer

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:

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 Design

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Study Type :	Observational
Actual Enrollment :	0 participants
Observational Model:	Cohort
Time Perspective:	Prospective
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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Buruli Ulcer

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Thermo Buruli ulcer patients receiving thermotherapy
Chemo Buruli ulcer patients receiving chemotherapy

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	1 Year to 100 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study population will include inhabitants of all health areas of the Akonolinga health district or coming from other BU endemic areas of Cameroon.

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Sponsors and Collaborators

Swiss Tropical & Public Health Institute

University Hospital Heidelberg

Centre International de Recherches, d'Enseignements et de Soins

Investigators

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Study Chair:	Thomas Junghanss, MD	University Hospital Heidelberg

More Information

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Responsible Party:	Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier:	NCT03969940
Other Study ID Numbers:	2018-13
First Posted:	May 31, 2019 Key Record Dates
Last Update Posted:	December 21, 2020
Last Verified:	November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Buruli Ulcer Ulcer Pathologic Processes Mycobacterium Infections, Nontuberculous Mycobacterium Infections	Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Skin Ulcer Skin Diseases

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