临床试验/NCT07308678

NCT07308678已完成不适用

Wound Closure in Venous Leg Ulcers (VLUs) Treated With AQUACEL® Ag+ Extra™ vs Cutimed® Sorbact®: A Blinded Re-Assessment of Randomized Controlled Trial Findings

ConvaTec Inc.1 个研究点分布在 1 个国家目标入组 105 人开始时间: 2025年4月22日最近更新: 2026年1月8日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: ConvaTec Inc.
入组人数: 105
试验地点: 1
主要终点: Wound closure at 12 weeks

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Study is to provide a blinded assessment of wound closure status utilizing photographs collected as per standard of care (SOC) during the AAA RCT (WC-22-435).

详细描述

The purpose of the study is to provide a blinded (treatment arm, timepoint) assessment of wound closure status utilizing photographs collected as per standard of care (SOC) during the AAA Randomized Controlled Trial (RCT) (WC-22-435).

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Retrospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•All subjects from the intention to treat (ITT) population with wound photograph(s) corresponding to the study visit date (WC-22-435) indicating wound closure or their 12-week visit, whichever came first

排除标准

•Subjects whose photographs are deemed of insufficient quality to make determination of closure

结局指标

主要结局

Wound closure at 12 weeks

时间窗: 12 week

Incidence of wound closure at 12 weeks, defined as 100% epithelialization of the wound surface, assessed by a blinded observer through photographic evidence

次要结局

未报告次要终点

研究者

发起方

ConvaTec Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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