Livedoid Vasculopathy: Strong Association With Smoking, W... | NCT05878327

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

NCT05878327

Sponsor

University of Zurich

Status

Completed

Last Update Posted

May 26, 2023Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Livedoid Vasculitis

Interventions

Thrombophilia screening

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Aug 3, 2014

First Submission Date that Met QC Criteria

May 17, 2023

First Posted Date

May 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2023

Last Update Posted Date

May 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thrombophilia screening		Patients with livedoid vasculopathy. Investigated by thrombophilia screening	Other: Thrombophilia screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thrombophilia screening	Other	No intervention. Blood is drawn for analysis.	Thrombophilia screening

Outcomes Module

Primary Outcomes

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.	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

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	The secondary endpoint is the search for thrombophilia in patients with livedoid vasculopathy.	22 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juerg Hafner, Prof, MD	University Hospital Zurich, Dept. of Dermatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital of Basel		Basel		4013	Switzerland
University hospital of Bern

Condition Browse Module

MeSH Terms

ID	Term
D000090122	Livedoid Vasculopathy
D012907	Smoking
D019851	Thrombophilia

Ancestor Terms

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided