A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial)
Juliana Puggina, Igor Rafael Sincos, Walter Campos, Rina Maria Pereira Porta, Jorgete Barreto dos Santos, Nélson De Luccia, Pedro Puech‐Leão, F. Collares, Erasmo Simão da Silva
Abstract
OBJECTIVES: To investigate whether radiofrequency endovenous ablation (RFA) of saphenous and perforating veins increases venous leg ulcer (VLU) healing rates and prevents ulcer recurrence. METHOD: This prospective, open-label, randomized, controlled, single-center trial recruited 56 patients with VLU divided into: compression alone (CR, N = 29) and RFA plus compression (RF, N = 27). Primary endpoints were ulcer recurrence rate at 12 months; and ulcer healing rates at 6, 12, and 24 weeks. Secondary endpoints were ulcer healing velocity; and Venous Clinical Severity Score (VCSS). RESULTS: Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001). There were no significant between-group differences in healing rates. Healing velocity was faster in the RF group (p = 0.049). In the RF group, 2 participants had type 1 endovenous heat-induced thrombosis (EHIT). CONCLUSIONS: Clinicaltrials.gov, NCT03293836, clinicaltrials.gov.