Buruli UlcerUB ThermoNCT03969940
Thermotherapy of Buruli Ulcer at Community Level in the Health District of Akonolinga
An observational study of Buruli Ulcer, run by Swiss Tropical & Public Health Institute.
Trial summary
The project rolls out combined innovative low-tech thermotherapy of Buruli ulcer (BU) with heat packs and WHO recommended wound management in a BU endemic district of Cameroon. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Buruli Ulcer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 30 Jun 2020
- 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 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include inhabitants of all health areas of the Akonolinga health district or coming from other BU endemic areas of Cameroon.
Who may be able to join
- Clinically diagnosed BU patients with a single WHO category I and II lesion
Who cannot join
- inappropriate lesion size (category III patients), location and patients with multiple lesions
About this study
The project rolls out combined innovative low-tech thermotherapy of Buruli ulcer (BU) with heat packs and WHO recommended wound management in a BU endemic district of Cameroon.
Read the detailed description
The project translates available clinical research findings at the secondary health care level into clinical practice at the primary health care and community level. The string of previous work from the development of the BU thermotherapy-wound management-package to the proof of its efficacy provides all necessary procedures, tools and documents to immediately proceed into practical and integrated community application.
Main objective:
To determine in patients with early BU lesions the effectiveness and acceptability of thermotherapy treatment at health post and community level.
Specific objectives:
- To monitor and evaluate clinical and biological responses to thermotherapy in patients receiving up to 8 weeks of thermotherapy
- To assess within 6 months after completion of heat treatment wound closure ("primary cure") and/or absence of BU specific features in included patients according to WHO healing criteria
- To measure the BU recurrence rate in included patient within 12 months after completion of heat treatment' ("definite cure").
- To assess the compliance rate of included patients
- To assess the withdrawal rate of included patients
- To assess the ability and comfort of health personnel to use the thermotherapy device
- Conditions
- Buruli Ulcer
- Medical subject headings
- Buruli Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thermo | Buruli ulcer patients receiving thermotherapy | |
| Chemo | Buruli ulcer patients receiving chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary cure: wound closure and/or no BU features according to WHO guideline
Number of patients with wound closure and/or absence of clinically BU specific features according to WHO guidelines within 6 months after completion of heat treatment
Measured: 6 months
Definite cure: No recurrence
Number of patients with no BU recurrence for 12 months after completion of heat treatment
Measured: 12 months
Secondary outcomes (2)
Acceptability
Rates of withdrawal (due to low compliance or consent withdrawal)
Measured: 2 years
Acceptability
Rating of thermotherapy by health staff
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 posted31 May 2019
- Study start1 Jan 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Why it stopped: Lack of supply of comparator drug in country
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Buruli UlcerStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, Centre International de Recherches, d'Enseignements et de Soins
- Responsible party
- Sponsor
- Investigators
- Thomas Junghanss, MD, Study chair, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969940
- Sponsor's protocol ID
- 2018-13
- Acronym
- UB Thermo
- Status last verified
- Nov 2020
- First submitted
- 23 May 2019
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermotherapy of Buruli Ulcer at Community Level in the Health District of Akonolinga
- ClinicalTrials.gov ID
- NCT03969940
- Acronym / sponsor ID
- UB Thermo / 2018-13
- Conditions
- Buruli Ulcer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of supply of comparator drug in country
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, Centre International de Recherches, d'Enseignements et de Soins
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 31 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 of Buruli ulcer (BU) with heat packs and WHO recommended wound management in a BU endemic district of Cameroon.
Detailed description
The project translates available clinical research findings at the secondary health care level into clinical practice at the primary health care and community level. The string of previous work from the development of the BU thermotherapy-wound management-package to the proof of its efficacy provides all necessary procedures, tools and documents to immediately proceed into practical and integrated community application.
Main objective:
To determine in patients with early BU lesions the effectiveness and acceptability of thermotherapy treatment at health post and community level.
Specific objectives:
- To monitor and evaluate clinical and biological responses to thermotherapy in patients receiving up to 8 weeks of thermotherapy
- To assess within 6 months after completion of heat treatment wound closure ("primary cure") and/or absence of BU specific features in included patients according to WHO healing criteria
- To measure the BU recurrence rate in included patient within 12 months after completion of heat treatment' ("definite cure").
- To assess the compliance rate of included patients
- To assess the withdrawal rate of included patients
- To assess the ability and comfort of health personnel to use the thermotherapy device
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermo | – | –Buruli ulcer patients receiving thermotherapy |
| Chemo | – | –Buruli ulcer patients receiving chemotherapy |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include inhabitants of all health areas of the Akonolinga health district or coming from other BU endemic areas of Cameroon.
Key inclusion criteria (1 listed)
- Clinically diagnosed BU patients with a single WHO category I and II lesion
Key exclusion criteria (1 listed)
- inappropriate lesion size (category III patients), location and patients with multiple lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary cure: wound closure and/or no BU features according to WHO guideline
Time frame: 6 months
Number of patients with wound closure and/or absence of clinically BU specific features according to WHO guidelines within 6 months after completion of heat treatment
Definite cure: No recurrence
Time frame: 12 months
Number of patients with no BU recurrence for 12 months after completion of heat treatment
2 secondary outcomes
Acceptability
Time frame: 2 years
Acceptability
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Thomas Junghanss, MD study chair
University Hospital Heidelberg
Questions about this trial
What is this clinical trial studying?
An observational study of Buruli Ulcer, run by Swiss Tropical & Public Health Institute.
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: withdrawn, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary cure: wound closure and/or no BU features according to WHO guideline (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2020.