Efficacy and safety of pentoxifylline for chronic venous leg ulcers: study protocol for a multicenter randomized controlled trial in China (ESPECT study).
Efficacy and safety of pentoxifylline for chronic venous leg ulcers: study protocol for a multicenter randomized controlled trial in China (ESPECT study).
复制标题
作者：
下肢静脉溃疡（VLU）是慢性静脉疾病最严重的表现，愈合时间长，复发率高。它给病人、他们的家庭和医疗保健系统带来了沉重的负担。由持续性静脉高压引发的慢性炎症现在被认为是慢性静脉疾病的标志。喷替福林的抗炎作用可能为治疗VLU提供一种有希望的途径。然而，目前关于喷替福林治疗VLU的证据相对较少且质量较低。本研究的目的是评价喷替福林在中国人群中治疗VLU的疗效和安全性。这是一项随机、双盲、双模拟、多中心、安慰剂对照的临床试验。共有240例患者将随机接受喷替福林（400 mg，每日两次）或安慰剂治疗24周。所有受试者将接受地奥司明治疗和VLU和其他合并症的标准护理。主要结局是喷替福林和安慰剂之间12周内伤口愈合率的差异。次要结局包括（1）12周时伤口大小变化百分比，（2）TNF-α和IL-6水平，（3）静脉临床严重程度评分和慢性静脉功能不全生活质量评分，以及（4）24周内溃疡复发。本研究将在中国人群中评价喷替福林治疗VLU的疗效和安全性。如果得到证实，它将为治疗VLU提供另一种有效和安全的治疗选择。该试验在中国临床试验注册中心注册（编号ChiCTR-2100053053）。于2021年11月10日注册，https://www.chictr.org.cn/showproj.aspx?项目=137010
Venous leg ulcers (VLUs) are the most severe manifestation of chronic venous disease, with long healing time and a high recurrence rate. It imposes a heavy burden on patients, their families, and the health care system. Chronic inflammation triggered by sustained venous hypertension is now recognized as the hallmark of chronic venous disease. The anti-inflammatory effect of pentoxifylline may offer a promising avenue to treat VLUs. However, current evidence of pentoxifylline for VLUs is relatively small and of low quality. The aim of this study is to evaluate the efficacy and safety of pentoxifylline for VLUs in the Chinese population. This is a randomized, double-blinded, double-dummy, multi-center, placebo-controlled clinical trial. A total of 240 patients will be randomized to receive pentoxifylline (400 mg, twice daily) or placebo for 24 weeks. All participants will receive diosmin treatment and standard care of VLUs and other comorbidities. The primary outcome is the difference in the wound healing rate within 12 weeks between pentoxifylline and placebo. Secondary outcomes include (1) percent wound size changes at 12 weeks, (2) the levels of TNF-α and IL-6, (3) venous clinical severity score and chronic venous insufficiency quality of life score, and (4) ulcer recurrence within 24 weeks. This study would evaluate the efficacy and safety of pentoxifylline for VLUs in the Chinese population. If confirmed, it wound offer another effective and safe therapeutic option for treatment of VLUs. The trial was registered at the Chinese Clinical Trial Registry (No. ChiCTR-2100053053). Registered on 10 November, 2021, https://www.chictr.org.cn/showproj.aspx?proj=137010