NCT05878327

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 3, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
8 years until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

August 3, 2014

Last Update Submit

May 17, 2023

Conditions

Keywords

Livedoid Vasculitissmokingthrombophilia

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    22 months

Study Arms (1)

Thrombophilia screening

Patients with livedoid vasculopathy. Investigated by thrombophilia screening

Other: Thrombophilia screening

Interventions

No intervention. Blood is drawn for analysis.

Thrombophilia screening

Eligibility Criteria

Age10 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • History of livedoid vasculopathy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University hospital of Basel

Basel, 4013, Switzerland

Location

University hospital of Bern

Bern, 3010, Switzerland

Location

University hospital Zurich

Zurich, 8091, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for thrombophilia screen.

MeSH Terms

Conditions

Livedoid VasculopathySmokingThrombophilia

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesBehaviorHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Juerg Hafner, Prof, MD

    University Hospital Zurich, Dept. of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2014

First Posted

May 26, 2023

Study Start

August 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 26, 2023

Record last verified: 2023-05

Locations