InflammationPYROCVDNCT03744858
The Role of Pyroptosis in Chronic Venous Disease
An observational study of Inflammation and Veins, run by University of Catanzaro at 1 site in Italy.
Trial summary
Enrollment criteria and clinical data collection: following the principles of medical ethics, the development of inclusion and exclusion criteria. Selecting 200 cases of chronic venous disease (CVD) according to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Veins, Complication
- What is being tested?
- Peripheral blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 12 Nov 2018to 12 Nov 2020
- 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: Patients with Chronic venous disease (CVD) according clinical stages of CEAP classification: C0: no visible or palpable signs of venous disease. C1: telangiectasies or reticular veins. C2: varicose veins. C3: edema. C4a: pigmentation and eczema. C4b: lipodermatosclerosis and atrophie blanche. C5: healed venous ulcer. C6: active venous ulcer.
Who may be able to join
- Chronic Venous Disease (C1-C6 CEAP classification )
Who cannot join
- Peripheral artery disease
- Malignant Tumors
- Severe cardiovascular and cerebrovascular disease
- Liver and kidney failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Pyroptosis in Chronic Venous Disease and Its Pathophysiological Implication
Enrollment criteria and clinical data collection: following the principles of medical ethics, the development of inclusion and exclusion criteria. Selecting 200 cases of chronic venous disease (CVD) according to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages (C1-C6) (Group A). Selecting 200 healthy participants without CVD (C0) as controls (Group B). Blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups, according to clinical stage, in group A.
Read the detailed description
Pyroptosis is a pro-inflammatory form of regulated cell death and is dependent on networks of extracellular fibers (NET,s), on the enzymatic activity of inflammatory proteases that belong to the family of cysteine-dependent aspartate-specific proteases (caspase), and cytokines. The role of inflammation has been previously demonstrated in chronic venous disease (CVD), which is a condition that affects up to 80% of adult population in western countries.
According to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages:
C0: no visible or palpable signs of venous disease. C1: telangiectasies or reticular veins. C2: varicose veins. C3: edema. C4a: pigmentation and eczema. C4b: lipodermatosclerosis and atrophie blanche. C5: healed venous ulcer. C6: active venous ulcer.
The aim of this study is to evaluate the role of pyroptosis in the onset and progression of CVD.
The Investigators will select 200 participants with chronic venous disease (CVD) according to Clinical stage of CEAP (C1-C6 patients) [Group A] . The investigators will also select 200 healthy participants without CVD (C0) as controls [Group B].
Peripheral vein blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups of group A, according to clinical stage.
- Conditions
- Inflammation, Veins, Complication, Varicose Veins, Varicose Ulcer
- Being tested
- Peripheral blood draw
- Keywords
- chronic vein disease, inflammation, pyroptosis
- Medical subject headings
- Inflammation, Varicose Veins, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood drawProcedure or surgery
Peripheral vein blood draw will be performed to all participants in order to collect blood samples to be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Participants with CVD | Patients with chronic venous disease (CVD) will undergo peripheral blood draw. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated in blood samples. Receives: Procedure: Peripheral blood draw | |
| Group B - Healthy Participants | Voluntary healthy subjects will undergo peripheral blood draw. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated in blood samples. Receives: Procedure: Peripheral blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pyroptosis evaluation 1
NETs evaluation to be presented in ng/ml
Measured: 2 years
Pyroptosis evaluation 2
Caspase-1 evaluation to be presented in pg/ml
Measured: 2 years
Pyroptosis evaluation 3
IL-1 β, IL-4, IL-10, IL-18, and TNF-α evaluation to presented in pg/ml
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start12 Nov 2018
- Primary completion12 Nov 2019 (estimated)
- Study completion12 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
- Investigators
- Raffaele Serra, MD, PhD, Principal investigator, University Magna Graecia of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744858
- Sponsor's protocol ID
- ER.CZ.2018.06
- Acronym
- PYROCVD
- Status last verified
- Nov 2018
- First submitted
- 12 Nov 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pyroptosis in Chronic Venous Disease and Its Pathophysiological Implication
- ClinicalTrials.gov ID
- NCT03744858
- Acronym / sponsor ID
- PYROCVD / ER.CZ.2018.06
- Conditions
- Inflammation, Veins, Complication, Varicose Veins, Varicose Ulcer
- Keywords
- chronic vein disease, inflammation, pyroptosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 12 Nov 2019 (estimated)
- Study completion
- 12 Nov 2020 (estimated)
- First posted
- 16 Nov 2018 (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.
Enrollment criteria and clinical data collection: following the principles of medical ethics, the development of inclusion and exclusion criteria. Selecting 200 cases of chronic venous disease (CVD) according to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages (C1-C6) (Group A). Selecting 200 healthy participants without CVD (C0) as controls (Group B). Blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups, according to clinical stage, in group A.
Detailed description
Pyroptosis is a pro-inflammatory form of regulated cell death and is dependent on networks of extracellular fibers (NET,s), on the enzymatic activity of inflammatory proteases that belong to the family of cysteine-dependent aspartate-specific proteases (caspase), and cytokines. The role of inflammation has been previously demonstrated in chronic venous disease (CVD), which is a condition that affects up to 80% of adult population in western countries.
According to the Comprehensive Classification System for Chronic Venous Disorders (CEAP) divided into 6 Clinical stages:
C0: no visible or palpable signs of venous disease. C1: telangiectasies or reticular veins. C2: varicose veins. C3: edema. C4a: pigmentation and eczema. C4b: lipodermatosclerosis and atrophie blanche. C5: healed venous ulcer. C6: active venous ulcer.
The aim of this study is to evaluate the role of pyroptosis in the onset and progression of CVD.
The Investigators will select 200 participants with chronic venous disease (CVD) according to Clinical stage of CEAP (C1-C6 patients) [Group A] . The investigators will also select 200 healthy participants without CVD (C0) as controls [Group B].
Peripheral vein blood samples will be collected from both groups. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated between the two groups and between the subgroups of group A, according to clinical stage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Participants with CVD | – | Procedure: Peripheral blood drawPatients with chronic venous disease (CVD) will undergo peripheral blood draw. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated in blood samples. |
| Group B - Healthy Participants | – | Procedure: Peripheral blood drawVoluntary healthy subjects will undergo peripheral blood draw. Markers of pyroptosis (NETs, Caspase-1 and Cytokines) will be evaluated in blood samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic venous disease (CVD) according clinical stages of CEAP classification: C0: no visible or palpable signs of venous disease. C1: telangiectasies or reticular veins. C2: varicose veins. C3: edema. C4a: pigmentation and eczema. C4b: lipodermatosclerosis and atrophie blanche. C5: healed venous ulcer. C6: active venous ulcer.
Key inclusion criteria (1 listed)
- Chronic Venous Disease (C1-C6 CEAP classification )
Key exclusion criteria (4 listed)
- Peripheral artery disease
- Malignant Tumors
- Severe cardiovascular and cerebrovascular disease
- Liver and kidney failure
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 |
|---|---|---|
| Peripheral blood drawPeripheral vein blood draw will be performed to all participants in order to collect blood samples to be evaluated. | Procedure or surgery | Group A - Participants with CVD, Group B - Healthy Participants |
Primary outcome
Pyroptosis evaluation 1
Time frame: 2 years
NETs evaluation to be presented in ng/ml
Pyroptosis evaluation 2
Time frame: 2 years
Caspase-1 evaluation to be presented in pg/ml
Pyroptosis evaluation 3
Time frame: 2 years
IL-1 β, IL-4, IL-10, IL-18, and TNF-α evaluation to presented in pg/ml
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
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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.
Raffaele Serra, MD, PhD principal investigator
University Magna Graecia of Catanzaro
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 Inflammation and Veins, run by University of Catanzaro 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 4 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 16 Nov 2018. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pyroptosis evaluation 1 (time frame: 2 years). The study lists 3 primary outcomes in all. 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 16 Nov 2018.