Ultrasound-guided foam sclerotherapy for chronic venous disease with ulcer. A prospective multiple outcome cohort study

Abstract Background Chronic Venous Disease (CVD) is the main cause of chronic leg ulcers. Varicose veins are the most frequent cause of venous leg ulcers (VLU). 50.9% of Brazilian women have varicose veins and ulcer prevalence is as high as 4%. Ultrasound-guided foam sclerotherapy (UGFS) is a low-cost treatment option for varicose veins. Objectives To analyze UGFS outcomes in patients with VLU. Methods Prospective consecutive single center cohort study. Patients with great saphenous vein (GSV) reflux and VLU were treated and followed-up for 180 days. The following were studied: quality of life (QoL), disease severity, healing, and elimination of GSV reflux. The Aberdeen questionnaire, a venous clinical severity score, and Duplex scanning (DS) results were analyzed. Results 22 patients aged 35 to 70 years were treated. There was improvement in quality of life, disease severity reduced, and ulcer diameter reduced (p < 0.001; ANOVA). 77.27% of VLU healed completely (95%CI: 59.76-94.78%). The dimensions of 20/22 VLU reduced (90.91%; 95%CI: 78.9-100%). GSV reflux was eliminated in 63.64% (95%CI: 43.54-83.74%). Men had greater QoL benefit and women had more complications. There were no severe complications. The VLU that had healed completely at the end of the study were smaller at baseline than those that did not completely heal. The GSV that were completely occluded at the end of the study were smaller at baseline than those that were not completely occluded (p < 0.05; Mann-Whitney). Conclusion The results suggest that most patients benefited from UGFS.

摘要

## 背景
慢性静脉疾病（Chronic Venous Disease, CVD）是慢性腿部溃疡的主要致病原因。静脉曲张是下肢静脉性溃疡（Venous Leg Ulcers, VLU）最常见的诱因。巴西有50.9%的女性罹患静脉曲张，溃疡患病率高达4%。超声引导下泡沫硬化疗法（Ultrasound-guided Foam Sclerotherapy, UGFS）是一种低成本的静脉曲张治疗方案。

## 研究目的
分析超声引导下泡沫硬化疗法（UGFS）对下肢静脉性溃疡（VLU）患者的治疗效果。

## 研究方法
本研究为单中心前瞻性连续队列研究。对合并大隐静脉（Great Saphenous Vein, GSV）反流及下肢静脉性溃疡（VLU）的患者实施治疗，并进行180天的随访。本研究考察的指标包括：生活质量（Quality of Life, QoL）、疾病严重程度、溃疡愈合情况以及大隐静脉反流消除情况。分析指标涵盖阿伯丁问卷（Aberdeen questionnaire）、静脉临床严重程度评分以及双功超声扫描（Duplex Scanning, DS）结果。

## 研究结果
本研究共纳入22名年龄介于35~70岁的患者接受治疗。患者的生活质量得到显著改善，疾病严重程度与溃疡直径均有所降低（p < 0.001；方差分析（Analysis of Variance, ANOVA））。77.27%的VLU实现完全愈合（95%置信区间：59.76%~94.78%）。20/22例VLU的病灶尺寸出现缩小（占比90.91%；95%置信区间：78.9%~100%）。63.64%的患者实现大隐静脉反流消除（95%置信区间：43.54%~83.74%）。男性患者的生活质量获益更为显著，女性患者的并发症发生率更高。本研究未出现严重并发症。研究结束时实现完全愈合的VLU，其基线病灶尺寸小于未完全愈合的病灶。研究结束时实现完全闭塞的大隐静脉，其基线管径小于未完全闭塞的大隐静脉（p < 0.05；曼-惠特尼检验（Mann-Whitney））。

## 研究结论
研究结果表明，多数患者可从UGFS治疗中获益。