Twelve-Month Results of Cyanoacrylate Closure in Patients with Venous Leg Ulceration.
Document Type
Article
Publication Title
Journal of vascular surgery. Venous and lymphatic disorders
Abstract
Importance: Venous leg ulceration (VLU) is a major cause of patient distress and healthcare burden. Previous studies have highlighted the importance of early endovenous ablation of superficial venous reflux to expedite healing and prevent recurrence, but the optimal venous ablation modality is unclear.
Objective: The aim of this study was to evaluate the effectiveness and safety of cyanoacrylate closure in patients with VLU.
Design: A global, prospective, single-arm observational study was conducted in 17 centers across the United States and Europe. A total of 125 participants with VLU were included and treated with the VenaSeal closure system, in addition to standard wound therapy, including multilayered compression. Adjuvant treatments to varicosities, perforators or the sub-ulcer plexus were left to the discretion of treating clinicians. The primary outcome was VLU healing through 12 months. Secondary outcomes included time to ulcer recurrence, anatomic vein closure, target limb adverse events, and changes in quality-of-life measures.
Results: One hundred twenty-five participants with VLU and saphenous vein reflux were enrolled. The mean (± standard deviation) age was 67.9 ± 14.76 years, with 38.4% females and an overall mean BMI of 32.4± 9.35. Concomitant foam sclerotherapy treatments were performed in 19.7% (31/157) of target veins. At 12 months, ulcer healing was 81.3% and ulcer recurrence was 17.0%. The median time to ulcer healing was 92 days (95% CI 74, 137). Anatomic vein closure was successful in 82.7% of all target veins. CEC-adjudicated AE and SAEs included: 2 granulomas, 1 hypersensitivity reaction, and 4 cases of phlebitis of the treated limb. Healthcare services utilized outside of the index procedure yielded 0.12 adjunctive therapies per vein-year. Venous-specific and generic QoL scores showed sustained improvement compared to baseline scores.
Conclusion: VenaSeal effectively eliminated saphenous reflux in patients with VLU. The ulcer healing rate was high, and the recurrence rate was low. Complication rates were also low and QoL improved.
First Page
102635
Last Page
102635
DOI
10.1016/j.jvsv.2026.102635
Publication Date
10-7-2026
Recommended Citation
Gibson K, Gohel M, Kayssi A, Sabat J, Néaume N, O'Banion LA, Gagne P, Kiguchi M, Khilnani NM, Kolluri R, Salkowski N, Denmark DJ, Davies AH. Twelve-Month Results of Cyanoacrylate Closure in Patients with Venous Leg Ulceration. J Vasc Surg Venous Lymphat Disord. 2026 Oct 7:102635. doi: 10.1016/j.jvsv.2026.102635. Epub ahead of print. PMID: 42843552.