Venous ulcer treatment with sclerofoam versus a conventional treatment: randomized prospective clinical trial

Introduction: Venous ulcers (VU) are the most common ulcers of the lower limb. It has a high morbidity and is a financial strain on the health system. Objective: The aim of this study was to determine the rate of healing VU with a conventional treatment versus the use of conventional treatment plus ultrasound-guided foam endoluminal occlusion. Material and methods: A prospective randomized clinical trial was conducted on patients attending the Vascular Surgery clinics in the Hospital Occidente de Kennedy-Bogota during 2011-2012. A total of 44 patients age 18 years and over, with venous insufficiency, VU, and an ankle-brachial index greater than 0.8, were included. A total of 48 extremities were analyzed in the two groups; one group a) Control: (conventional treatment with non-compressive bandages, vaseline gauze, and wound care) and b) Study group: control treatment plus endoluminal occlusion with ultrasound-guided foam in the superficial venous system by Tessari method using 1% lapidium hydrochloride (sklerol). Follow-up was carried out at week 3, 8, 12 and 24. Results: The healing rate of the ulcer at week 24 was 20 (83.3%) extremities healed by the endoluminal occlusion with ultrasound-guided foam group vs. 3 (12.5%) extremities healed in the group using the conventional treatment (P=.0005). No major complications arising from treatment were observed in either group. Conclusion: The healing rates of the VU after endoluminal occlusion with ultrasound-guided foam is safe and effective. This minimally invasive technique is far superior to conventional treatment with non-compressive bandages, vaseline gauze, and wound care, exclusively. Registration number of this study: NCT01594658 in clinical trials. (C) 2014 SEACV. Published by Elsevier Espana, S.L.U. All rights reserved.