NCT05680636

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 21, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

January 21, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

September 21, 2022

Last Update Submit

January 10, 2023

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • presence of DVT

    baseline

Interventions

temperature measurementDIAGNOSTIC_TEST

Differential Leg Skin Temperature Measured With Handheld Low-cost Infrared Thermometers.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Patients suspected of deep vein thrombosis.

You may not qualify if:

  • under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Studio Medico

Gessate, Milano, 20060, Italy

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Laurent Mapelli, Bsc (HOns)

    Accademia Italiana Medicina Osteopatica

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent Mapelli, Bsc (HOns)

CONTACT

‭+39 338 5846868‬laurent.mapelli@docenti.aimoedu.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research

Study Record Dates

First Submitted

September 21, 2022

First Posted

January 11, 2023

Study Start

January 21, 2023

Primary Completion

September 21, 2023

Study Completion

September 21, 2023

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

IT(1)