NCT00399308已完成1 期
An Initial Evaluation Of The Safety And Activity Of Celaderm(TM) Treatment Regimens In Healing Venous Leg Ulcers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 40
- 试验地点
- 18
- 主要终点
- Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation.
研究概览
简要总结
This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.
详细描述
Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R) compression vs. Profore(R) compression alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •venous ulcer > 1 month and < 12 months in duration; 2 to 20 sq cm in surface area; not infected
- •confirmatory venous ultrasound showing prior DVT and concurrent venous reflux
- •ankle-brachial index 0.80 or greater
排除标准
- •cutaneous malignancy
- •recent treatment with corticosteroids or chemotherapeutic agents
- •wound exposed bone, tendon or neurovascular structure
- •wound infected and requiring antibiotics
结局指标
主要结局
Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation.
时间窗: 12 weeks
The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.)
次要结局
- Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.(12 Weeks)
- Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).(24 weeks)
- Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.(Variable - minimum of 12 weeks of follow-up.)
研究者
研究点 (18)
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