New Clinical Score for Deep Vein Thrombosis

January 10, 2023 updated by: ALESSANDRA ABENAVOLI, Accademia Italiana Medicina Osteopatica

A New Clinical Score for Deep Vein Thrombosis: the Role of Differential Leg Skin Temperature Measured With Handheld Low-cost Infrared Thermometers.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Contact

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

  • Patients suspected of deep vein thrombosis.

Exclusion Criteria:

  • under 18 years of age

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

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
presence of DVT
Time Frame: baseline
baseline

Collaborators and Investigators

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

Sponsor

Accademia Italiana Medicina Osteopatica

Investigators

  • Principal Investigator: Laurent Mapelli, Bsc (HOns), Accademia Italiana Medicina Osteopatica

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 (Anticipated)

January 21, 2023

Primary Completion (Anticipated)

September 21, 2023

Study Completion (Anticipated)

September 21, 2023

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Estimate)

January 11, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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