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Treat Early and Broad: Thermotherapy of Buruli Ulcer Integrated Into WHOrecommended Wound Management in West Africa (WOUNDCARE)

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ClinicalTrials.gov Identifier: NCT03957447
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
Centre Suisse de Recherches Scientifiques (CSRS)
Information provided by (Responsible Party):
Martin Koch, University Hospital Heidelberg

Tracking Information
First Submitted Date May 17, 2019
First Posted Date May 21, 2019
Last Update Posted Date May 23, 2019
Actual Study Start Date May 7, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2019)
  • Prevalence of skin ulcers in inhabitants of the Taabo health district, Ivory Coast [ Time Frame: 2 years ]
    To measure the frequency and the severity of skin lesions (broken skin barrier) in the community and the health services
  • Qualitative description of factors determining public health services-based skin ulcer managment [ Time Frame: 2 years ]
    Description of facilitating and obstructive factors for recognition and treatment of ulcers (questionnaires, interviews, patient and institution-related documentation of costs)
  • Frequency and severity of skin ulcers after community health service intervention [ Time Frame: 2 years ]
    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.
  • Number of patients with healed skin ulcers identified in the survey (see outcome 1) [ Time Frame: 2 years ]
    To measure the proportion of ulcers healed at each cycle of clinical diagnosis and corresponding presumptive treatment
  • Number of patients presenting at the health posts level with skin ulcers identified in the survey (see above) [ Time Frame: 2 years ]
    To describe the clinical epidemiology of different types of skin ulcers (wounds) presented (presumptive clinical and confirmed diagnoses)
  • Quality of care for patients with skin ulcers identified in the survey (see above) [ Time Frame: 2 years ]
    Coverage and quality of skin ulcer (wound) management training of health care personnel at the peripheral health care level (health posts)
  • Outcome of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy study [ Time Frame: 2 years ]
    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").
Original Primary Outcome Measures
 (submitted: May 20, 2019)
  • Survey skin wounds a [ Time Frame: 2 years ]
    To measure the frequency and the severity of skin lesions (broken skin barrier) in the community and the health services
  • Survey skin wounds b [ Time Frame: 2 years ]
    To investigate the determining factors of community and health services-based wound management
  • Survey skin wounds c [ Time Frame: 2 years ]
    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.
  • Patients with wounds identified in the survey (see above) a [ Time Frame: 2 years ]
    To measure the proportion of wounds healed (defined as wound closed) at each cycle of clinical diagnosis and corresponding presumptive treatment
  • Patients with wounds identified in the survey (see above) b [ Time Frame: 2 years ]
    To describe the clinical epidemiology of wounds presented (presumptive clinical and confirmed diagnoses)
  • Patients with wounds identified in the survey (see above) c [ Time Frame: 2 years ]
    Coverage and quality of wound management training of health care personnel at the peripheral health care level (health posts)
  • Patients with Buruli ulcers < 2cm and willing to participate in thermotherapy study [ Time Frame: 2 years ]
    Absence of clinically Buruli ulcer 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").
Change History Complete list of historical versions of study NCT03957447 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 21, 2019)
  • Drop out rate of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy [ Time Frame: 2 years ]
    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
  • Withdrawal of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy [ Time Frame: 2 years ]
    Number of participants with consent withdrawal
  • Patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy [ Time Frame: 2 years ]
    Rating of skin ulcer thermotherapy by health staff of the Taabo health distric, Ivory Coast, measured by a score based on a questionnaire
Original Secondary Outcome Measures
 (submitted: May 20, 2019)
  • Patients with Buruli ulcers < 2cm and willing to participate in thermotherapy study a [ Time Frame: 2 years ]
    Rates of withdrawal for low compliance
  • Patients with Buruli ulcers < 2cm and willing to participate in thermotherapy study b [ Time Frame: 2 years ]
    Consent withdrawal
  • Patients with Buruli ulcers < 2cm and willing to participate in thermotherapy study c [ Time Frame: 2 years ]
    Rating of thermotherapy by health staff
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treat Early and Broad: Thermotherapy of Buruli Ulcer Integrated Into WHOrecommended Wound Management in West Africa
Official Title Treat Early and Broad: Thermotherapy of Buruli Ulcer Integrated Into WHOrecommended Wound Management in West Africa
Brief 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).
Detailed 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 (12, 13, 14). 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Skin Ulcer
  • Buruli Ulcer
  • Nontuberculous Mycobacteria
Intervention Other: thermotherapy (application of heat)
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.
Study Groups/Cohorts
  • patients exhibiting skin wounds
    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.
  • patients identified in the survey and willing to participate
    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.
  • patients exhibiting Buruli ulcers < 2cm
    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.
    Intervention: Other: thermotherapy (application of heat)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2019)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Bassirou Bonfoh, PhD +22507078083 mailto:bassirou.bonfoh@csrs.ci
Contact: Thomas Junghanss, MD +491634270831 Thomas.Junghanss@urz.uni-heidelberg.de
Listed Location Countries Côte D'Ivoire
Removed Location Countries  
 
Administrative Information
NCT Number NCT03957447
Other Study ID Numbers WOUNDCAREV2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: A RedCap datashare platform is in place already. Individual patient data will be provided anonymised.
Responsible Party Martin Koch, University Hospital Heidelberg
Study Sponsor University Hospital Heidelberg
Collaborators Centre Suisse de Recherches Scientifiques (CSRS)
Investigators
Principal Investigator: Marija Stojkovic, MD University Hospital Heidelberg, Germany
PRS Account University Hospital Heidelberg
Verification Date May 2019