NCT00270972Unknown不适用
A Confirmatory Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (ORCEL) for the Treatment of Venous Ulcers
Ortec International20 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 20
- 主要终点
- Investigator Assessment of wound healing
研究概览
简要总结
This study was designed to confirm the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care are compared to standard care alone. Standard care consists of currently accepted compression therapy.
Patients are treated for 12 weeks. Patients with healed ulcers are followed for an additional 12 weeks to assess durability of the healed wound.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any race, between 18 and 85 years of age
- •Male or female
- •Chronic venous insufficiency
- •Ulcer size between 2 and 20 sq cm, inclusive
- •Ulcer present for at least one month
- •ABI >0.7
排除标准
- •Decrease in wound size >35% during Screening Phase
- •Infection at ulcer site
- •Uncontrolled diabetes mellitus
- •Malnutrition
- •Previous treatment with excluded medications
结局指标
主要结局
Investigator Assessment of wound healing
次要结局
- Planimetric assessment of wound healing
- Photographic assessment of wound healing
研究者
研究点 (20)
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