NCT00852995已完成2 期
A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Healthpoint
- 入组人数
- 228
- 试验地点
- 60
- 主要终点
- The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.
研究概览
简要总结
This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Provide informed consent.
- •Willing to comply with protocol instructions, including allowing all study assessments.
- •Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus.
- •Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
- •Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months.
排除标准
- •Women who are pregnant or lactating
- •Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
- •A target ulcer of non-venous etiologies.
- •Refusal of or inability to tolerate compression therapy.
- •Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit.
- •Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.
结局指标
主要结局
The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.
时间窗: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.
次要结局
- Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13(Over the 12 week treatment period or until the wound closed, which ever occurred first.)
- Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.(14 weeks - the final visit for one subject was delayed by two weeks)
- Kaplan-Meier Probability of Non-Closure(14 weeks - the final visit for one subject was delayed by two weeks)
- Percentage of Participants With Complete Wound Closure at Each Visit(Weekly, over the 12 week treatment period)
- Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.(Weekly, over the 12 week treatment period)
- Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.(Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first)
研究者
研究点 (60)
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