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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-06-30

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:

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

Conditions

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Buruli Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Thermo

Buruli ulcer patients receiving thermotherapy

No interventions assigned to this group

Chemo

Buruli ulcer patients receiving chemotherapy

No interventions assigned to this group

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Junghanss, MD

Role: STUDY_CHAIR

University Hospital Heidelberg

Other Identifiers

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2018-13

Identifier Type: -

Identifier Source: org_study_id