Treatment of venous leg ulcers by cyanoacrylate glue: A prospective study of safety and feasibility

Background VLUs continue to be a major source of disability. They frequently develop in patients without previous deep vein thrombosis. The objective of this study was to evaluate the safety and feasibity of non-thermal ablation, using cyanoacrylate, combining great saphenous vein (GSV) closure and ultrasound-guided perforator embolization in patients with primary valvular incompetence, who have active (VLUs) (CEAP C6). Methods This prospective ETUVVE (Étude, Traitement, Ulcères, Variqueux, Venaseal) study was a single-center feasibility trial. Patients with active venous ulcers were selected using clinical and duplex ultrasound assessments. Treatment involved cyanoacrylate embolization of the GSV, combined with glue injections targeting incompetent perforators or tributaries where appropriate. Patients were monitored for up to 12 months, with assessments of ulcer healing, vein occlusion, pain, clinical severity, symptoms, quality of life, and adverse events. Results Between January 2021 and December 2022, 38 patients with CEAP class C6 were enrolled. The ulcer healing rate was 90.6% at one year, with healing observed in 15.6% of patients by 8 days, 34.3% by 30 days, and 81.2% by 6 months. No ulcer recurrences were recorded within the one-year. Pain (VAS), Venous Clinical Severity Score (VCSS), symptom scores (VEINES-Sym), and quality of life scores (VEINES-QoL) improved significantly during follow-up. No major adverse events related to the glue were reported; 10 patients had 12 minor adverse events, including hypersensitivity reaction at the injection site and superficial thrombophlebitis that developed in one patient each. Conclusion Cyanoacrylate glue appears to be a safe and effective treatment for patients with active VLUs (CEAP class C6), achieving high healing rates and improving symptoms, clinical severity, and quality of life with a low risk of adverse events. Larger randomized studies are warranted to confirm these results.