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Thrombosis biomarkers after varicose vein treatment using foam injection and conventional surgery

Peripheral blood thrombosis biomarkers after great saphenous vein reflux treatment using polidocanol foam chemical ablation and conventional saphenectomy - None: None

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-47pnrf
Enrollment
Unknown
Registered
2019-12-27
Start date
2019-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose veins without ulcer or inflamation

Interventions

Chemical ablation group: 35 patients of both sexes, all ethnic groups and aging 18-80 years presenting with lower limbs symptomatic varicose veins with great saphenous vein reflux will be submitted to
Procedure/surgery

Sponsors

Universidade de São Paulo - Faculdade de Medicina de Ribeirão Preto
Lead Sponsor
Universidade de São Paulo - Faculdade de Medicina de Ribeirão Preto
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Symptomatic varicose veins; age 18-80 years; great saphenous veins total or partial reflux in one or both limbs, detected by duplex ultrasound.

Exclusion criteria

Exclusion criteria: Significant active comorbidity; infectious disease (infected ulcer); thrombophilia; previous tromboembolic event; anticoagulant or antiplatelet use; pregnancy; increased cardiovascular risk.

Design outcomes

Primary

MeasureTime frame
Through determination of peripheral blood thrombosis biomarkers: -Thrombin antithrombin complex -D dimers -Trombomodulin -Von Willebrand factor antigen -Soluble P selectin; we expect finding variation between the two therapeutic methods.

Secondary

MeasureTime frame
Through application of quality of life scores CIVIQ and Aberdeen, we expect finding variation between the two therapeutic methods. ;Through Doppler ultrasound, we will determine the great saphenous vein post treatment status, which can be classified: -Oclusion -Partial recanalisation without reflux -Partial recanalisation with reflux. -Total recanalisation We expect finding variation between the two therapeutic methods.

Countries

Brazil

Contacts

Public ContactMarcelo Dalio

Universidade de São Paulo - Faculdade de Medicina de Ribeirão Preto

mbdalio@usp.br+55 16 3602 25 93

Outcome results

None listed

Source: REBEC (via WHO ICTRP)