Livedoid VasculitisNCT05878327
Livedoid Vasculopathy: Strong Association With Smoking, Weak Association With Thrombophilia
An observational study of Livedoid Vasculitis, run by University of Zurich at 3 sites in Switzerland.
Trial summary
A screening of patient histories at the clinics of Dermatology of the universities of Zurich, Basel and Bern is performed in order to identify patients with a history of Livedoid vasculopathy. Patients with a history of livedoid vasculopathy are asked to participate in the study. Read more about this study
- Who is it for?
- Ages 10 to 85 years
- Conditions the study is for
- Livedoid Vasculitis
- What is being tested?
- Thrombophilia screening
- How many people
- 15 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Aug 2013to Jun 2015
- 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 10 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated for livedoid vasculopathy at the clinics of Dermatology of the University hospitals of Zurich, Basel and Bern.
Who may be able to join
- History of livedoid vasculopathy
Who cannot join
- Diagnosis was not proved by biopsy specimen
- A different reason than livedoid vasculopathy has been found for the symptoms of the patient
- No informed consent by the patient
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
University hospital of Basel
Basel, 4013
University hospital of Bern
Bern, 3010
University hospital Zurich
Zurich, 8091
About this study
A screening of patient histories at the clinics of Dermatology of the universities of Zurich, Basel and Bern is performed in order to identify patients with a history of Livedoid vasculopathy. Patients with a history of livedoid vasculopathy are asked to participate in the study. After reading the patient information and if the informed consent is signed patients are included in the study. Patients are questioned about their smoking history and blood is drawn in order to perform a screening for thrombophilia.
Read the detailed description
A screening of patient histories at the clinics of Dermatology of the universities of Zurich, Basel and Bern is performed in order to identify patients with a history of Livedoid vasculopathy. Patients with a history of livedoid vasculopathy are asked to participate in the study. The presence of Livedoid vasculopathy must be confirmed by a histologic specimen. After reading the patient information and if the informed consent is signed patients are included in the study. Patients are questioned about their smoking history and blood is drawn in order to perform a screening for thrombophilia. The presence of a history of smoking and thrombophilia is compared to the general Swiss population.
- Conditions
- Livedoid Vasculitis
- Being tested
- Thrombophilia screening
- Keywords
- Livedoid Vasculitis, smoking, thrombophilia
- Medical subject headings
- Livedoid Vasculopathy, Smoking, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombophilia screeningOther
No intervention. Blood is drawn for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Thrombophilia screening | Patients with livedoid vasculopathy. Investigated by thrombophilia screening Receives: Other: Thrombophilia screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking history: Patients will be asked if they currently smoke or if they are former smokers. If one of both items is yes, it means a positive answer.
The primary endpoint is the comparison of a positive smoking history and other cardiovascular risk factors of patients with livedoid vasculopathy with the Swiss general population.
Measured: 22 months
Secondary outcomes (1)
Thrombophilia screening: the following parameters will be determined in every participant: Factor V Leiden, Prothrombin 20210; Protein C, Protein S, Antithrombin III, Beta 2 Glykoprotein 1, Lupus Antikoagulans
The secondary endpoint is the search for thrombophilia in patients with livedoid vasculopathy.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study startAug 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Livedoid VasculitisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juerg Hafner, Prof, MD, Principal investigator, University Hospital Zurich, Dept. of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878327
- Sponsor's protocol ID
- KEK-ZH-Nr. 2013-0301
- Status last verified
- May 2023
- First submitted
- 3 Aug 2014
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Livedoid Vasculopathy: Strong Association With Smoking, Weak Association With Thrombophilia
- ClinicalTrials.gov ID
- NCT05878327
- Acronym / sponsor ID
- KEK-ZH-Nr. 2013-0301
- Conditions
- Livedoid Vasculitis
- Keywords
- Livedoid Vasculitis, smoking, thrombophilia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 May 2023 (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.
A screening of patient histories at the clinics of Dermatology of the universities of Zurich, Basel and Bern is performed in order to identify patients with a history of Livedoid vasculopathy. Patients with a history of livedoid vasculopathy are asked to participate in the study. After reading the patient information and if the informed consent is signed patients are included in the study. Patients are questioned about their smoking history and blood is drawn in order to perform a screening for thrombophilia.
Detailed description
A screening of patient histories at the clinics of Dermatology of the universities of Zurich, Basel and Bern is performed in order to identify patients with a history of Livedoid vasculopathy. Patients with a history of livedoid vasculopathy are asked to participate in the study. The presence of Livedoid vasculopathy must be confirmed by a histologic specimen. After reading the patient information and if the informed consent is signed patients are included in the study. Patients are questioned about their smoking history and blood is drawn in order to perform a screening for thrombophilia. The presence of a history of smoking and thrombophilia is compared to the general Swiss population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thrombophilia screening | – | Other: Thrombophilia screeningPatients with livedoid vasculopathy. Investigated by thrombophilia screening |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated for livedoid vasculopathy at the clinics of Dermatology of the University hospitals of Zurich, Basel and Bern.
Key inclusion criteria (1 listed)
- History of livedoid vasculopathy
Key exclusion criteria (3 listed)
- Diagnosis was not proved by biopsy specimen
- A different reason than livedoid vasculopathy has been found for the symptoms of the patient
- No informed consent by the patient
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 |
|---|---|---|
| Thrombophilia screeningNo intervention. Blood is drawn for analysis. | Other | Thrombophilia screening |
Primary outcome
Smoking history: Patients will be asked if they currently smoke or if they are former smokers. If one of both items is yes, it means a positive answer.
Time frame: 22 months
The primary endpoint is the comparison of a positive smoking history and other cardiovascular risk factors of patients with livedoid vasculopathy with the Swiss general population.
1 secondary outcome
Thrombophilia screening: the following parameters will be determined in every participant: Factor V Leiden, Prothrombin 20210; Protein C, Protein S, Antithrombin III, Beta 2 Glykoprotein 1, Lupus Antikoagulans
Time frame: 22 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
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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.
Juerg Hafner, Prof, MD principal investigator
University Hospital Zurich, Dept. of Dermatology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Livedoid Vasculitis, run by University of Zurich at 3 sites in Switzerland.
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 3 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: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Smoking history: Patients will be asked if they currently smoke or if they are former smokers. If one of both items is yes, it means a positive answer. (time frame: 22 months). 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 26 May 2023.