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

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.

Study Overview

• Status: Withdrawn
• Conditions: 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:

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: University Hospital Heidelberg; Centre International de Recherches, d'Enseignements et de Soins
• Investigators: Study Chair: Thomas Junghanss, MD, University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Infections; Skin Ulcer; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous; Ulcer; Buruli Ulcer
• Other Study ID Numbers: 2018-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No