NCT02119754已完成2 期
Open Label Trial of Topical PluroGel PN for the Treatment of Patients With Mildly Infected Diabetic Foot Ulcer CLINICAL PROTOCOL PGN-1300X
PluroGen Therapeutics, Inc15 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 15
- 主要终点
- Clinical Response
研究概览
简要总结
This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects who have failed treatment on Protocol PGN-1300X
排除标准
- 未提供
研究组 & 干预措施
Plurogel PN
Experimental
Plurogel PN
干预措施: Plurogel PN (Drug)
结局指标
主要结局
Clinical Response
时间窗: 14 days
Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.
次要结局
未报告次要终点
研究者
研究点 (15)
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