Overview

This trial is active, not recruiting.

Condition varicose vein of lower limbs
Treatments short catheter, long catheter preceded by tumescence
Sponsor University of Sao Paulo
Start date December 2014
End date December 2016
Trial size 50 participants
Trial identifier NCT02753270, 12683

Summary

Foam sclerotherapy has been established as another option of treatment for varicose veins of the lower limbs. Its advantages are the application to patients with high surgical risk and immediate return to usual activities. Comparing to laser and radiofrequency, it has lower cost and is less painful. Nevertheless, it requires more re-interventions due to venous recanalization.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Twenty-five patients will receive the sclerosant foam by a short catheter 18 G. They will be treated with 3% polidocanol foam prepared with a three-way tap and two plastic disposable syringes, according to Tessari's method.
short catheter
Ultrasound Guided Foam Sclerotherapy in Great Saphenous Vein, measuring from 6 to 10 mm, with Short Catheter.
(Experimental)
Twenty-five patients will be receive foam sclerosant by an angiographic catheter 4 French. They will be treated with 3% polidocanol foam prepared with a three-way tap and two plastic disposable syringes, according to Tessari's method.
long catheter preceded by tumescence
Ultrasound Guided Foam Sclerotherapy Transcatheter in Great Saphenous Vein, measuring from 6 to 10 mm, Preceded by Tumescence.

Primary Outcomes

Measure
Great Saphenous Vein Occlusion Rate
time frame: Six months after the intervention

Secondary Outcomes

Measure
Quality of Life Change
time frame: Six months follow-up after the intervention
Complications
time frame: From the intervention until six months follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age equal to or greater than 18 years; - patients with varicose veins with edema - CEAP classification C3EpAsPr; - Great saphenous vein incompetence, segmental and total, with diameter from 6 to 10 mm in proximal thigh, 3 cm from the saphenous femoral junction measured by ultrasound. Exclusion Criteria: - Allergy to the sclerosant substance; - acute deep vein thrombosis or pulmonary thromboembolism; - local infection in the area of sclerotherapy or severe systemic infection; - prolonged immobilisation; - symptomatic patent foramen ovale; - pregnancy; - peripheral arterial occlusive disease; - short saphenous vein incompetence association; - refusal to sign the consent form; - nonadherence to outpatient treatment.

Additional Information

Official title Ultrasound Guided Foam Sclerotherapy Transcatheter in Great Saphenous Vein, Preceded of Tumescence. Randomized Controlled Trial.
Description The aim of this study is to compare two ultrasound guided foam sclerotherapy (UGFS) techniques to great saphenous vein (GSV) by injecting the sclerosant foam through a short catheter without perivenous tumescence and through a long catheter with saline anesthetic tumescence. Method: selection of 50 patients with primary varicose veins, edema (C3EpAsPr of the CEAP classification) and with GSV measuring 6 - 10 mm, 3 cm below the saphenofemoral junction, identified by ultrasound. The study is taking place at the vascular surgery ambulatory of the University of São Paulo. It is a prospective controlled trial with random allocation in two groups according to the foam sclerosant technique injection. The group 1 will receive the sclerosant foam by a short catheter 18 G and in the group 2 an angiographic catheter 4 Fr. will be used. All patients will be treated with 3% polidocanol foam prepared with a three-way tap and two plastic disposable syringes, according to Tessari's method. The access will be by puncture and its place will depend on the insufficient venous extension. It will be at the level of the knee to treat proximal GSV or at the medial ankle to treat the full length of the vein. In group 2, after inserting the long catheter into the GSV, a saline anesthetic solution will be infiltrated around the insufficient venous segment under ultrasound guidance to reduce its diameter. The long catheter will be continuously flushed with 0.9% saline solution until the foam sclerosant injection. In the cases of treating only the proximal GSV, patients will receive a continuous compression with tourniquet below the knee just before the injection and maintained for 5 minutes thereafter. Then, the tributaries in all 50 patients will be treated by phlebectomy under tumescent local anesthesia. Color-duplex ultrasound follow-up is programmed to 7, 28 and 168 days after the treatment. The first one is to check the possibility of deep venous thrombosis, the second is to verify the occlusion rate and the need of another foam injection. The last ultrasound is to check the recanalization. Hypothesis: UGFS with long catheter preceded of tumescence has a large occlusion rate of the GSV with monotherapy.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Sao Paulo.