An observational study in Skin Ulcer, Buruli Ulcer and Nontuberculous Mycobacteria, sponsored by University Hospital Heidelberg. Status unknown at 1 site in Côte D'Ivoire. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by University Hospital Heidelberg · Observational
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:
Operational endpoints are
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
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 effectiveness and acceptability of thermotherapy of patients with early BU (\< 2cm) treated at health post level with the following outcomes:
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.
79 studies on the registry are indexed under Skin Ulcer; 14 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 92 across 10 observational studies indexed under Skin Ulcer.
Browse Skin Ulcer studies →University Hospital Heidelberg is the lead sponsor of 175 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients in Taabo Health District (HDSS), Ivory Coast 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.
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
Within the framework of Taabo HDSS Cross-sectional community and health services surveys are performed before wound management intervention (main study and substudy 1) is implemented (baseline) and are continued at 6 monthly intervals thereafter. Surveys are done door-to-door. All patients with skin lesions (broken skin barrier) are enrolled, lesions are documented with help of a questionnaire and photographic documentation.
Each patient with a wound will be enrolled. Presumptive clinical diagnosis and empirical treatment, as well wound assessment, will be recorded at enrollment and at each follow-up visit. Additional laboratory testing done within the framework of the local health system will also be recorded.
Buruli ulcer patients fulfilling inclusion criteria will be offered thermotherapy instead of standard antibiotic treatment. 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.
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.
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
Time frame: 2 years
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)
Time frame: 2 years
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.
Time frame: 2 years
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
Time frame: 2 years
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)
Time frame: 2 years
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)
Time frame: 2 years
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").
Time frame: 2 years
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
Time frame: 2 years
Withdrawal of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy
Number of participants with consent withdrawal
Time frame: 2 years
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
Time frame: 2 years
Plan to share: Undecided — A RedCap datashare platform is in place already. Individual patient data will be provided anonymised.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Buruli Ulcer
University Hospital Heidelberg