Livedo VasculitisNCT00975871
Correlation of Genetic Polymorphism and Livedo Vasculitis
An observational study of Livedo Vasculitis and Livedoid Vasculitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Livedo vasculitis is disease with recurrent courses of painful foot or ankle ulcerations, followed by healed white scars. The actual mechanism of its pathophysiology is not yet clear. It has been reported to be associated with some gene mutations, for example, factor V Leiden gene. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Livedo Vasculitis, Livedoid Vasculitis, Livedoid Vasculopathy
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2007to Apr 2009
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General population
Who may be able to join
- Clinical diagnosis of livedo vasculitis
Who cannot join
- No special exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Livedo vasculitis is disease with recurrent courses of painful foot or ankle ulcerations, followed by healed white scars. The actual mechanism of its pathophysiology is not yet clear. It has been reported to be associated with some gene mutations, for example, factor V Leiden gene. This study is aimed to find the possible relation of these gene mutations in Taiwanese patients.
Read the detailed description
Livedo vasculitis is a chronic, recurrent painful ulcerations on the ankles and feet. This chronic disease is characterized by healed white, atrophic scars named atrophie blanche. The histopathological exam on the lesion site reveals fibrin deposition within the vessel walls. It has been reported to be related to factor V Leiden mutation (heterozygous) (22.2%), prothrombin G20210A gene mutation (8.3%), PAI promotor 4G/4G genotype and methylenetetrahydrofolate reductase (MTHFR) C677T mutation in about total 30% livedo vasculitis patients. This study is trying to find the correlation between Taiwanese patients and these four genes.
- Conditions
- Livedo Vasculitis, Livedoid Vasculitis, Livedoid Vasculopathy, Genetic Pleomorphism, Leiden Mutation
- Keywords
- Livedo vasculitis, Genetic pleomorphism
- Medical subject headings
- Livedoid Vasculopathy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Livedo VasculitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tsen-Fang Tsai, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975871
- Sponsor's protocol ID
- 0961172000
- Status last verified
- Oct 2009
- First submitted
- 11 Sep 2009
- Last updated
- 23 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Genetic Polymorphism and Livedo Vasculitis
- ClinicalTrials.gov ID
- NCT00975871
- Acronym / sponsor ID
- 0961172000
- Conditions
- Livedo Vasculitis, Livedoid Vasculitis, Livedoid Vasculopathy, Genetic Pleomorphism, Leiden Mutation
- Keywords
- Livedo vasculitis, Genetic pleomorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 14 Sep 2009 (estimated)
- 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.
Livedo vasculitis is disease with recurrent courses of painful foot or ankle ulcerations, followed by healed white scars. The actual mechanism of its pathophysiology is not yet clear. It has been reported to be associated with some gene mutations, for example, factor V Leiden gene. This study is aimed to find the possible relation of these gene mutations in Taiwanese patients.
Detailed description
Livedo vasculitis is a chronic, recurrent painful ulcerations on the ankles and feet. This chronic disease is characterized by healed white, atrophic scars named atrophie blanche. The histopathological exam on the lesion site reveals fibrin deposition within the vessel walls. It has been reported to be related to factor V Leiden mutation (heterozygous) (22.2%), prothrombin G20210A gene mutation (8.3%), PAI promotor 4G/4G genotype and methylenetetrahydrofolate reductase (MTHFR) C677T mutation in about total 30% livedo vasculitis patients. This study is trying to find the correlation between Taiwanese patients and these four genes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population
Key inclusion criteria (1 listed)
- Clinical diagnosis of livedo vasculitis
Key exclusion criteria (1 listed)
- No special exclusion criteria
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
Not reported in the source record.
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 23 Oct 2009.
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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.
Tsen-Fang Tsai, MD principal investigator
National Taiwan University Hospital
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 Livedo Vasculitis and Livedoid Vasculitis, run by National Taiwan University Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 23 Oct 2009. 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 Taiwan. 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.
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 23 Oct 2009.