New Clinical Score for Deep Vein Thrombosis

Sponsor
Accademia Italiana Medicina Osteopatica (Other)
Overall Status
Recruiting
CT.gov ID
NCT05680636
Collaborator
(none)
500
1
8
62.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: temperature measurement

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A New Clinical Score for Deep Vein Thrombosis: the Role of Differential Leg Skin Temperature Measured With Handheld Low-cost Infrared Thermometers.
Anticipated Study Start Date :
Jan 21, 2023
Anticipated Primary Completion Date :
Sep 21, 2023
Anticipated Study Completion Date :
Sep 21, 2023

Outcome Measures

Primary Outcome Measures

  1. presence of DVT [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients suspected of deep vein thrombosis.
Exclusion Criteria:
  • under 18 years of age

Contacts and Locations

Locations

Site City State Country Postal Code
1 Studio Medico Gessate Milano Italy 20060

Sponsors and Collaborators

  • Accademia Italiana Medicina Osteopatica

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ALESSANDRA ABENAVOLI, Head of Research, Accademia Italiana Medicina Osteopatica
ClinicalTrials.gov Identifier:
NCT05680636
Other Study ID Numbers:
  • 002
First Posted:
Jan 11, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2023