Deep Vein ThrombosisNCT05680636
New Clinical Score for Deep Vein Thrombosis
An observational study of Deep Vein Thrombosis, run by Accademia Italiana Medicina Osteopatica at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- temperature measurement
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jan 2023to 21 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
Who may be able to join
- Patients suspected of deep vein thrombosis.
Who cannot join
- under 18 years of age
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Studio Medico
Gessate, Milano, 20060
Laurent Mapelli, Bsc (HOns), +39 338 5846868, laurent.mapelli@docenti.aimoedu.it
About this study
Official title: 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.
- Conditions
- Deep Vein Thrombosis
- Being tested
- temperature measurement
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temperature measurementDiagnostic test
Differential Leg Skin Temperature Measured With Handheld Low-cost Infrared Thermometers.
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of DVT
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start21 Jan 2023 (estimated)
- Primary completion21 Sep 2023 (estimated)
- Study completion21 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Accademia Italiana Medicina Osteopatica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALESSANDRA ABENAVOLI, Accademia Italiana Medicina Osteopatica
- Investigators
- Laurent Mapelli, Bsc (HOns), Principal investigator, Accademia Italiana Medicina Osteopatica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680636
- Sponsor's protocol ID
- 002
- Status last verified
- Jan 2023
- First submitted
- 21 Sep 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Clinical Score for Deep Vein Thrombosis: the Role of Differential Leg Skin Temperature Measured With Handheld Low-cost Infrared Thermometers.
- ClinicalTrials.gov ID
- NCT05680636
- Acronym / sponsor ID
- 002
- Conditions
- Deep Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Accademia Italiana Medicina OsteopaticaUniversity, hospital or other
- Study start
- 21 Jan 2023 (estimated)
- Primary completion
- 21 Sep 2023 (estimated)
- Study completion
- 21 Sep 2023 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- Patients suspected of deep vein thrombosis.
Key exclusion criteria (1 listed)
- under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temperature measurementDifferential Leg Skin Temperature Measured With Handheld Low-cost Infrared Thermometers. | Diagnostic test | – |
Primary outcome
presence of DVT
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Mapelli, Bsc (HOns) principal investigator
Accademia Italiana Medicina Osteopatica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis, run by Accademia Italiana Medicina Osteopatica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent Mapelli, Bsc (HOns) (+39 338 5846868, laurent.mapelli@docenti.aimoedu.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of DVT (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.