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Treatment of Varicose Veins by Injection of Foam guided by Ultrasound

Treatment of Varicose Veins by Foam Sclerotherapy Ultrasound-guided

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-67d69p
Enrollment
Unknown
Registered
2016-08-03
Start date
2015-09-01
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

Venous Insufficiency, Varicose Veins, Obesity

Interventions

Experimental group: in patients members 91, elastic sock compression will be oriented in the first 48 hours
and the use of stocking by a further period of 3 weeks after the completion of 1 or 2 sessions with foam sclerotherapy (Polidocanol) via transdermal selected vein puncture with administration of 2 ml
Procedure/surgery

Sponsors

Hospital Universitário da Universidade Federal de Sergipe
Lead Sponsor
Hospital Universitário da Universidade Federal de Sergipe
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Aged between 18 and 60 years inclusive. Male and female sex. Informed consent authorization. Reflux diagnosed by Doppler ultrasound in any saphenous vein extension and / or trunk varicose veins measuring between 4 and 8mm in diameter inclusive. Varicose veins classified APEC 3,4,5 and 6. Body mass index (BMI) between 25 and 40kg/m2.

Exclusion criteria

Exclusion criteria: Patient with psychiatric disorder or limitation in the technique compreendimento. Women during pregnancy or risk pregnancy (without effective contraception) or nursing. Patients with a personal history of deep vein thrombosis and / or PET. Patients with known allergy to Polidocanol (synonyms: Lauromacrogol 400, macrogollauryleter, PEG9lauryl-alcohol). Patients with severe or chronic decompensated (hepatic insufficiency, renal insufficiency, CHF, COPD, respiratory insufficiency, progressive, malignant disease, hypertension and / or diabetes mellitus uncompensated). Intra-atrial or ventricular septal defect diagnosed by echocardiography. Closing of / attend the scheduled follow-ups. Patients who have Peripheral Arterial Disease Installed (ankle-brachial index less than 0, 9)

Design outcomes

Primary

MeasureTime frame
The expected primary outcome will be complete luminal occlusion of the vessel underwent embolization with polidocanol and use or non-use of elastic stockings for long periods. The method used to check the expected outcome will be the vascular echo doppler in 3 weeks, 3 months and 6 months after the procedure. The parameter that will be used to check the outcome actually occurred will be the absence of detectable speed through the vascular echo Doppler that show what actually occurred thrombosis within the vessel.

Secondary

MeasureTime frame
The expected secondary outcome will be the presence of local and / or systemic complications of treatment. The method used to check the expected outcome will be the vascular clinical examination carried out in 3 weeks, 3 months and 6 months after the procedure. The parameter used to verify that the outcome actually occurred will be the presence of areas of dermal necrosis, tomboflebite symptomatic deep vein thrombosis, visual disturbances, chest pain, allergic reaction and death.

Countries

Brazil

Contacts

Public ContactMarco Nunes

Universidade Federal de Sergipe

nunes.ma@ufs.br+55(79)21051811

Outcome results

None listed

Source: REBEC (via WHO ICTRP)