Venous Ulcer: Could Endovenous Radiofrequency Ablation Improve Ulcer Healing? Preliminary Results of a Randomized Controlled Trial

Abstract

Venous leg ulcers can take several weeks or months to heal and typically present with repeated cycles of ulceration, healing, and recurrence that result in high treatment costs and have a negative impact on patients’ quality of life. The multicomponent compression bandage system is still regarded as the “gold standard” to treat venous ulceration since previous randomized controlled trials failed to show improvement in ulcer healing rates by venous insufficiency surgical treatment despite decrease of ulcer recurrence risk. The current study was designed to investigate whether radiofrequency endovenous ablation of saphenous and perforating insufficient veins could increase venous ulcer healing rates. We did a prospective, controlled, randomized, open-label trial at a single center in Brazil. Participants had venous leg ulcer related to saphenous and perforating vein insufficiency with no sign of current or previous deep venous thrombosis. We randomly assigned participants to receive a weekly-changed two-layer compression bandage system alone or surgical radiofrequency ablation of insufficient saphenous and perforating veins before starting to receive the same compression system. Participants were stratified by ulcer duration (>6 months or <6 months) and ulcer area (>5 cm2 or <5 cm2). The primary end points were ulcer healing rates 6, 12, and 24 weeks after start of treatment. From January 2015 to August 2017, there were 77 patients considered eligible for the study, but 21 participants were excluded before randomization because of treatment abandonment, pretreatment wound healing, ultrasound evidence of previous unknown deep venous thrombosis, and clinical deterioration. The 56 remaining patients were randomly allocated to two treatment groups: 29 to multicomponent compression bandage alone and 27 to combined surgical and compressive treatment. The study is still ongoing, and 24 patients have been under intervention. We have therefore considered for analysis 15 participants from the surgical group and 17 participants from the isolated compressive treatment group. There are no statistically significant differences between groups in ulcer healing rates after 6 weeks. However, after 12 weeks, 73% of surgically treated patients have their ulcers healed vs 65% of compression alone-treated patients (hazard ratio, 4.968; 95% confidence interval, 1.053-23.42; P = .043). After 24 weeks, ulcer healing rate differences are even more evident (100% vs 76%), with the chance of healing greater for the surgical group (hazard ratio, 6.278; 95% confidence interval, 1.693-23.28; P = .006). Until now, 12- and 24-week venous ulcer healing rates were significantly greater in participants treated by endovenous radiofrequency ablation of saphenous and perforating veins plus two-layer compressive bandages than in patients who were treated with compression alone. We expect this difference to be maintained until the end of the study.