NCT00953563撤回不适用
The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Wound healing pathway markers
研究概览
简要总结
The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, compression therapy alone for the treatment of venous leg ulcers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •venous ulcer confirmed w/ duplex ultrasound
- •ulcer greater than 6 months duration
- •post-debridement, the ulcer size must be >5cm2
- •at least 18 years old
- •ABI is between 0.7 to 1.2 and/or one of the following:
- •TcPO2 > 30mmHg at the ankle
- •Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
- •able and willing to provide a voluntary written informed consent
- •three or fewer ulcers separated by >3.0 cm distance
- •able and willing to attend scheduled follow-up visits and study related exams
排除标准
- •greater than 20% reduction in wound size during the first 2 weeks of observation with the investigator
- •ulcer with exposed bone or tendon
- •clinical infection at the studied ulcer site including cellulitis and osteomyelitis
- •ulcer of a non-venous insufficiency etiology
- •phlebitis or deep leg vein thrombosis in past 30 days
- •arterial bypass in previous 30 days
- •severe anemia (Hgb<8)
- •serum albumin <3.0
- •uncompensated congestive heart failure
- •renal failure with Creatinine >2.5mg/dl
- •rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
- •severe liver disease as defined by treating physician
- •uncontrolled diabetes mellitus determined by treating physician
- •malignancy at or near the ulcer site
- •any condition judged by the PI that would cause the study to be detrimental to the patient
- •known allergy to equine derived tissue
- •received another investigational device or drug within 30 days of Day 0
- •radiation therapy at the wound site
- •chemotherapy or immunosuppressive therapy within 30 days of enrollment
- •received another allograft, autograft, xenograft within 30 days of the study
- •pregnant or nursing women
结局指标
主要结局
Wound healing pathway markers
时间窗: baseline, day 0, 3, wk 1, 2
次要结局
- Bacterial Bioburder(baseline, day 0, 3, wk 1, 2)
研究者
研究点 (6)
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