Livedoid Vasculopathy: Strong Association With Smoking, Weak Association With Thrombophilia

May 17, 2023 updated by: University of Zurich
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4013
        • University Hospital of Basel
      • Bern, Switzerland, 3010
        • University Hospital of Bern
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated for livedoid vasculopathy at the clinics of Dermatology of the University hospitals of Zurich, Basel and Bern.

Description

Inclusion Criteria:

  • History of livedoid vasculopathy

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thrombophilia screening
Patients with livedoid vasculopathy. Investigated by thrombophilia screening
Other: Thrombophilia screening
No intervention. Blood is drawn for analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
22 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The secondary endpoint is the search for thrombophilia in patients with livedoid vasculopathy.
22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Juerg Hafner, Prof, MD, University Hospital Zurich, Dept. of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 3, 2014

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-Nr. 2013-0301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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