Skin UlcerWOUNDCARENCT03957447
Treat Early and Broad: Thermotherapy of Buruli Ulcer Integrated Into WHO-recommended Wound Management in West Africa
An observational study of Skin Ulcer and Buruli Ulcer, run by University Hospital Heidelberg at 1 site in Côte d’Ivoire.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Ulcer, Buruli Ulcer, Nontuberculous Mycobacteria
- What is being tested?
- thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemia
- How many people
- 5,000 participants
- Where
- 1 siteCôte d’Ivoire
- Study dates
- 7 May 2019to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
CSRS
Abidjan, 1303
Bassirou Bonfoh, PhD, +22507078083, mailto:bassirou.bonfoh@csrs.ci
About this study
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.
Read more
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).
Read the 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. 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.
- Conditions
- Skin Ulcer, Buruli Ulcer, Nontuberculous Mycobacteria
- Being tested
- thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemia
- Keywords
- skin wounds, Ivory Coast community health services, prevalence study, thermotherapy
- Medical subject headings
- Skin Ulcer, Buruli Ulcer, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemiaOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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").
Measured: 2 years
Secondary outcomes (3)
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
Measured: 2 years
Withdrawal of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy
Number of participants with consent withdrawal
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start7 May 2019
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin UlcerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Suisse de Recherches Scientifiques en Cote d'Ivoire, Institut Pasteur de Côte d'Ivoire, Abidjan Cocody CHU, Côte d'Ivoire
- Responsible party
- Principal investigator, Martin Koch, University Hospital Heidelberg
- Investigators
- Marija Stojkovic, MD, Principal investigator, University Hospital Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957447
- Sponsor's protocol ID
- WOUNDCAREV2
- Acronym
- WOUNDCARE
- Status last verified
- Jan 2023
- First submitted
- 17 May 2019
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A RedCap datashare platform is in place already. Individual patient data will be provided anonymised.
Publications
Toppino S, Koffi DY, Kone BV, N'Krumah RTAS, Coulibaly ID, Tobian F, Pluschke G, Stojkovic M, Bonfoh B, Junghanss T. Community-based wound management in a rural setting of Cote d'Ivoire. PLoS Negl Trop Dis. 2022 Oct 13;16(10):e0010730. doi: 10.1371/journal.pntd.0010730. eCollection 2022 Oct.
PubMed 36227844Toppino S, N'Krumah RTAS, Kone BV, Koffi DY, Coulibaly ID, Tobian F, Pluschke G, Stojkovic M, Bonfoh B, Junghanss T. Skin wounds in a rural setting of Cote d'Ivoire: Population-based assessment of the burden and clinical epidemiology. PLoS Negl Trop Dis. 2022 Oct 13;16(10):e0010608. doi: 10.1371/journal.pntd.0010608. eCollection 2022 Oct.
PubMed 36227839
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treat Early and Broad: Thermotherapy of Buruli Ulcer Integrated Into WHO-recommended Wound Management in West Africa
- ClinicalTrials.gov ID
- NCT03957447
- Acronym / sponsor ID
- WOUNDCARE / WOUNDCAREV2
- Conditions
- Skin Ulcer, Buruli Ulcer, Nontuberculous Mycobacteria
- Keywords
- skin wounds, Ivory Coast community health services, prevalence study, thermotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Centre Suisse de Recherches Scientifiques en Cote d'Ivoire, Institut Pasteur de Côte d'Ivoire, Abidjan Cocody CHU, Côte d'Ivoire
- Study start
- 7 May 2019 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemiaBuruli 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemiaHeat 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 | patients exhibiting Buruli ulcers < 2cm |
Primary outcome
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").
3 secondary outcomes
Drop out rate of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy
Time frame: 2 years
Withdrawal of patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy
Time frame: 2 years
Patients with Buruli ulcers < 2cm and willing to participate in thermotherapy substudy
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 36227844Toppino S, Koffi DY, Kone BV, N'Krumah RTAS, Coulibaly ID, Tobian F, Pluschke G, Stojkovic M, Bonfoh B, Junghanss T. Community-based wound management in a rural setting of Cote d'Ivoire. PLoS Negl Trop Dis. 2022 Oct 13;16(10):e0010730. doi: 10.1371/journal.pntd.0010730. eCollection 2022 Oct.
- Derived from this study: PubMed 36227839Toppino S, N'Krumah RTAS, Kone BV, Koffi DY, Coulibaly ID, Tobian F, Pluschke G, Stojkovic M, Bonfoh B, Junghanss T. Skin wounds in a rural setting of Cote d'Ivoire: Population-based assessment of the burden and clinical epidemiology. PLoS Negl Trop Dis. 2022 Oct 13;16(10):e0010608. doi: 10.1371/journal.pntd.0010608. eCollection 2022 Oct.
- Individual participant dataSharing planned: Undecided. A RedCap datashare platform is in place already. Individual patient data will be provided anonymised.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marija Stojkovic, MD principal investigator
University Hospital Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Ulcer and Buruli Ulcer, run by University Hospital Heidelberg at 1 site in Côte d’Ivoire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bassirou Bonfoh, PhD (+22507078083, mailto:bassirou.bonfoh@csrs.ci), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of skin ulcers in inhabitants of the Taabo health district, Ivory Coast (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03957447, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.