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

Skin Ulcer Clinical Trial

— WOUNDCARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03957447
• Other study ID #: WOUNDCAREV2
• Status: Recruiting
• Start date: May 7, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2023
• Source: University Hospital Heidelberg
• Contact: Bassirou Bonfoh, PhD
• Phone: +22507078083
• Email: mailto:bassirou.bonfoh[@]csrs.ci
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Overall goal of the study To contribute to a better understanding of the clinical epidemiology of wounds and wound healing and to improve wound management in settings with limited resources at the community level, the primary and secondary level of the health care services.

Study objectives Main study

• To measure the proportion of wounds healed (defined as wound closed) at each cycle of clinical diagnosis and the corresponding presumptive treatment

• To describe the clinical epidemiology of wounds presented (presumptive clinical and confirmed diagnoses)

• Coverage and quality of wound management training of health care personnel at the peripheral health care level (health posts); Substudy 1

• To measure the effectiveness and acceptability of thermotherapy of patients with early BU (< 2cm) treated at health post level with the following outcomes:

• Primary endpoints absence of clinically BU specific features' according to WHO guidelines or 'wound closure' within 6 months after completion of heat treatment ("primary cure") and 'absence of BU recurrence for 12 months after completion of heat treatment' ("definite cure").

• Secondary outcomes rates of withdrawal for low compliance consent withdrawal rating of thermotherapy by health staff Substudy 2

• To measure the frequency and the severity of skin lesions (broken skin barrier) in the community and the health services

• To investigate the determining factors of community and health services-based wound management

• To measure the impact of the wound management intervention (main study and substudy 1) on the frequency, spectrum and severity of wounds including systemic complications in the community and at the 7 health posts / district hospital (HDSS-based) compared to the baseline study before the intervention and over time after the implementation of the intervention.

Target Population The target population are approximately 43,000 people of the Taabo HDSS which is surveyed longitudinally for key demographic, health and socioeconomic indicators since 2008. This provides ideal conditions to implement the intervention and assess the impact through operational endpoints. The health centres and the district hospital involved are part of the public health system. There is one district hospital and the seven health posts within the Taabo DHSS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Survey All HDSS population members Wound management study Patients with wounds defined as broken skin barrier. Thermotherapy study Buruli ulcer patients of the main study with ulcers < 2cm.

Exclusion Criteria:

none

Related Conditions & MeSH terms

• Buruli Ulcer
• Nontuberculous Mycobacteria
• Skin Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Côte D'Ivoire	CSRS	Abidjan

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Centre Suisse de Recherches Scientifiques en Cote d'Ivoire, Institut Pasteur de Côte d'Ivoire, Abidjan Cocody CHU, Côte d'Ivoire

Country where clinical trial is conducted

Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of skin ulcers in inhabitants of the Taabo health district, Ivory Coast	To measure the frequency and the severity of skin lesions (broken skin barrier) in the community and the health services	2 years
Primary	Qualitative description of factors determining public health services-based skin ulcer managment	Description of facilitating and obstructive factors for recognition and treatment of ulcers (questionnaires, interviews, patient and institution-related documentation of costs)	2 years
Primary	Frequency and severity of skin ulcers after community health service intervention	To measure the impact of the wound management intervention (main study and substudy 1) on the frequency, spectrum and severity of wounds including systemic complications in the community and at the health posts / district hospital compared To the baseline study before intervention and over time after implementation of the intervention.	2 years
Primary	Number of patients with healed skin ulcers identified in the survey (see outcome 1)	To measure the proportion of ulcers healed at each cycle of clinical diagnosis and corresponding presumptive treatment	2 years
Primary	Number of patients presenting at the health posts level with skin ulcers identified in the survey (see above)	To describe the clinical epidemiology of different types of skin ulcers (wounds) presented (presumptive clinical and confirmed diagnoses)	2 years
Primary	Quality of care for patients with skin ulcers identified in the survey (see above)	Coverage and quality of skin ulcer (wound) management training of health care personnel at the peripheral health care level (health posts)	2 years
Primary	Outcome of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy study	Number of patients completing thermotherapy exhibiting no more signs of clinically Buruli ulcer (BU) specific features' according to WHO guidelines or 'wound closure' within 6 months after completion of heat treatment ("primary cure") and 'absence of BU recurrence for 12 months after completion of heat treatment' ("definite cure").	2 years
Secondary	Drop out rate of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy	Number of participants of the thermotherapy substudy not included in analysis of healing rate (see outcome 7) due to lack of cooperation or failure to return for assessment	2 years
Secondary	Withdrawal of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy	Number of participants with consent withdrawal	2 years
Secondary	Patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy	Rating of skin ulcer thermotherapy by health staff of the Taabo health distric, Ivory Coast, measured by a score based on a questionnaire	2 years