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Treat Early and Broad: Thermotherapy of Buruli Ulcer Integrated Into WHO-recommended Wound Management in West Africa

NCT03957447 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2023-01-04

No results posted yet for this study

Summary

The project rolls out combined innovative low-tech thermotherapy with heat packs and WHO recommended wound management in a Buruli ulcer (BU)-endemic district of West Africa. It addresses three key areas of considerable clinical and public health importance in the region:

* to better help people managing the disabling disease BU that primarily affects children in West Africa
* to implement WHO recommended general wound management for all types of wounds with tools available at the peripheral level of the health care system
* to prevent systemic life threatening sequelae (e.g. sepsis and rheumatic fever) and permanent local damage (e.g. motor and sensory disability) by early recognition and treatment of wounds at the community level. The project translates available research findings already validated on the secondary health care level into clinical practice at the periphery (primary health care level). The string of the investigator's previous work from the development of the BU thermotherapy-wound management-package to the proof of its efficacy provides all necessary skills, tools and documents to immediately proceed into practical community application.

Operational endpoints are

* coverage and quality of WHO recommended wound management training of health care personnel at the primary health care level (health posts);
* coverage, success rate and quality of care for patients with BU and other wounds; denominator controlled at health post level and high-quality Health and Demographic Surveillance Systems (HDSS) data.

The project is embedded into a stable multidisciplinary working environment at Côte d'Ivoire, including an HDSS with a longstanding record of partnership and successful community-based operational research.

The project builds on the principles laid out by the Sustainable Development Goals (SDGs) and Universal Health Coverage (UHC) and

* targets all patients with a broken down skin barrier independent of the cause (patient centred health care)
* brings diagnosis and treatment close to the community
* educates and trains both community members and health care workers
* measures the health intervention outcome The project is fully in line with the new integrated strategy for the skin NTDs of WHO's Department of Control of NTDs (WHO/NTD).

Conditions

  • Skin Ulcer
  • Buruli Ulcer
  • Nontuberculous Mycobacteria

Interventions

OTHER

thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemia

Heat treatment is applied for 42 days plus a safety margin of up to 14 days, if ulcer margins have not fully collapsed and/or induration has not fully subsided. Treatment terminates earlier, if a lesion is completely closed. Thermotherapy will be applied with heat packs twice daily.

Sponsors & Collaborators

  • Centre Suisse de Recherches Scientifiques en Cote d'Ivoire

    collaborator OTHER

  • Institut Pasteur de Côte d'Ivoire, Abidjan Cocody CHU, Côte d'Ivoire

    collaborator UNKNOWN

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Marija Stojkovic, MD · University Hospital Heidelberg, Germany

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2024-06-30
Completion
2024-09-30

Countries

  • Côte d’Ivoire

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03957447 on ClinicalTrials.gov