Bertanha Matheus, Sobreira Marcone Lima, Pinheiro Lúcio Filho Carlos Eduardo, de Oliveira Mariúba Jamil Victor, Farres Pimenta Rafael Elias, Jaldin Rodrigo Gibin, Moroz Andrei, Moura Regina, Rollo Hamilton Almeida, Yoshida Winston Bonetti
Department of Surgery and Orthopedics, School of Medicine, São Paulo State University (UNESP), Rubião Junior s/n, CEP 18,618-970 Botucatu, SP, Brazil.
Trials. 2014 Dec 19;15:497. doi: 10.1186/1745-6215-15-497.
The prevalence of chronic venous disease is high and occurs more frequently in females. According to the clinical, etiological, anatomical, and pathological classification (CEAP) definition, the reticular veins are included in the C1 class and are mainly associated with aesthetic complaints. Several invasive techniques are used for treatment, including mini phlebectomy, laser ablation, and radiofrequency ablation. However, a wide range of sclerosing agents may serve as minimally invasive alternatives, promoting chemical sclerosis of the vein wall. Although this technique is routinely performed around the world, there is no consensus on the most efficacious and safe chemical agent to be used.
METHODS/DESIGN: Inclusion criteria are women between 18 and 69 years old with at least 10 cm long reticular veins in the lower limbs, on the outer side of the leg/thigh. Patients with CEAP 2 to 6, or with allergies, pregnancy, performing breastfeeding, or with any dermatologic or clinical problems will be excluded. Patients with venous ultrasound mapping showing involvement of saphenous trunks and/or a deep venous system will also be excluded. Patients will be randomized into two groups, one receiving 75% pure glucose and the other group receiving 0.2% polidocanol diluted in 70% glucose. Just one limb and one session per patient will be performed. The sclerosing agent volume will not exceed 5 mL. Clinical follow-up will include visits on days 7 and 60, always with photographic documentation.
This project aims to enroll 96 patients and subject them to a double-blind treatment after the randomization process. The design is intended to evaluate efficacy through a primary end point and safety through a secondary end point. Forty-eight patients have currently been enrolled. Preliminary results for these patients showed that 25 received treatment, 2 were excluded, and 22 returned after 7 days and showed no greater adverse events. To date, establishing efficacy criteria has not been possible, and no patients have reached the 60-day return point. These data may help doctors choose the best chemical agent for the treatment of reticular veins.
ClinicalTrials.gov Identifier: NCT02054325, 3/02/2014.
慢性静脉疾病患病率较高，且在女性中更为常见。根据临床、病因、解剖和病理分类（CEAP）定义，网状静脉属于C1级，主要与美观问题相关。有多种侵入性技术可用于治疗，包括微小静脉切除术、激光消融和射频消融。然而，多种硬化剂可作为微创替代方法，促进静脉壁化学性硬化。尽管该技术在全球范围内常规开展，但对于使用哪种最有效且安全的化学药剂尚无共识。
方法/设计：纳入标准为年龄在18至69岁之间、下肢外侧腿部/大腿有至少10厘米长网状静脉的女性。CEAP分级为2至6级、有过敏史、怀孕、正在进行母乳喂养或有任何皮肤病或临床问题的患者将被排除。静脉超声检查显示隐静脉主干和/或深静脉系统受累的患者也将被排除。患者将被随机分为两组，一组接受75%纯葡萄糖，另一组接受用70%葡萄糖稀释的0.2%聚多卡醇。每位患者仅对一条肢体进行一次治疗。硬化剂用量不超过5毫升。临床随访包括在第7天和第60天进行访视，每次均需拍照记录。
本项目旨在招募96名患者，随机分组后对其进行双盲治疗。该设计旨在通过主要终点评估疗效，通过次要终点评估安全性。目前已招募48名患者。这些患者的初步结果显示，25名接受了治疗，2名被排除，22名在7天后复诊，未出现更严重的不良事件。迄今为止，尚未能够确定疗效标准，且尚无患者达到60天复诊时间点。这些数据可能有助于医生选择治疗网状静脉的最佳化学药剂。
ClinicalTrials.gov标识符：NCT02054325，2014年2月3日。
