New Clinical Score for Deep Vein Thrombosis | NCT05680636

Studies
New Clinical Score for Deep Vein Thrombosis

NCT05680636

Sponsor

Accademia Italiana Medicina Osteopatica

Status

Unknown status

Last Update Posted

Jan 11, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Deep Vein Thrombosis

Interventions

temperature measurement

Countries

Italy

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

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 21, 2023Estimated

Primary Completion Date

Sep 21, 2023Estimated

Completion Date

Sep 21, 2023Estimated

First Submitted Date

Sep 21, 2022

First Submission Date that Met QC Criteria

Jan 10, 2023

First Posted Date

Jan 11, 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

Jan 10, 2023

Last Update Posted Date

Jan 11, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ALESSANDRA ABENAVOLI, Head of Research, Accademia Italiana Medicina OsteopaticaPrincipal Investigator

Lead Sponsor

Accademia Italiana Medicina OsteopaticaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 new Clinical Score (CS) to rule out Deep Vein Thrombosis (DVT) has to be derived and internally validated (with bootstrap method), from patients suspected of DVT in Italy. Primary care physicians (general practitioners) in Lombardy will be instructed to inform patients suspected of DVT about this research and get in touch with the team to get details and, eventually, volunteer for the study. The CS includes categorical variables and a continuous variable: the differential leg skin temperature measured with a low-cost handheld infrared thermometer in object surface mode.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
temperature measurement	Diagnostic Test	Differential Leg Skin Temperature Measured With Handheld Low-cost Infrared Thermometers.

Measure	Description	Time Frame
presence of DVT		baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients suspected of deep vein thrombosis.

Exclusion Criteria:

under 18 years of age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Suspicion of deep vein thrombosis should be based on the presence of at least one of the following signs/symptoms

unilateral swelling of the lower limbs
unilateral erythema of the lower limbs
unilateral pain in the lower limbs

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laurent Mapelli, Bsc (HOns)	Contact	‭+39 338 5846868‬		laurent.mapelli@docenti.aimoedu.it

Overall Officials

Name	Affiliation	Role
Laurent Mapelli, Bsc (HOns)	Accademia Italiana Medicina Osteopatica	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Studio Medico	Recruiting	Gessate	Milano	20060	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020246	Venous Thrombosis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided