Cyanoacrylate Closure For Treatment Of Venous Leg Ulcers

An open label, prospective single centre, single arm clinical trial enrolling patients with active venous ulcers with a planned enrollment of 20 patients was conducted to evaluate the effectiveness and safety of cyanoacrylate closure combined with standard of care compression therapy for the treatment of venous leg ulcers in the setting of an incompetent saphenous vein. Inclusion criteria were active venous ulceration, saphenous vein reflux confirmed by duplex ultrasound (US) and ankle brachial index ≥0.9. Primary outcomes included change in ulcer size, ulcer healing and adverse events at three months. At three months, 50.0% of ulcers were healed (14/28), and 56.2% of subjects were ulcer-free (10/19). At 12 months, 79.2.% of ulcers were healed (19/24), and 68.8% of subjects were ulcer-free (11/16 The average percent reduction in ulcer size at three months and 12 months was 88.1% and 95.6%, respectively. Cyanoacrylate closure of an incompetent saphenous vein was shown to be safe and effective for treating patients with chronic venous leg ulcers.