A Feasibility, Double Blind, Randomized, Controlled Clinical Study to Evaluate the Safety of Topically Applied Revera vs. Control in Subjects With Venous Leg Ulcers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Tabulations of AEs (Adverse Event), review of CBC (Complete Blood Count) with differential and platelet.
研究概览
简要总结
The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.
详细描述
The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.
This evaluation will be done through tabulations of adverse events (AE), review of complete blood counts (CBC) with differential and platelet, and measuring wound healing rate.
The secondary purpose of the study is a preliminary evaluation of an increase in the healing rate of venous leg ulcers treated with Revera Wound Care.
This evaluation will be done through measuring wound healing rate (which is also being used to evaluate safety) and complete wound healing.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18 years of age or older.
- •Diagnosis of non-healing venous leg ulcer by the following criteria:
- •dependent peripheral edema, dermatitis, hyperpigmentation.
- •an ankle to arm arterial pressure ratio > 0.7 as measured by arterial Doppler.
- •Venous Stasis Ulcer is ≥ 2 cm² in size.
- •If female subject of reproductive age, have had a negative pregnancy test within one week of study entry and are using adequate birth control.
排除标准
- •Subject known to be allergic to Aquacel dressing or components.
- •Peripheral arterial insufficiency (as determined by Doppler ABI), uncontrolled congestive heart failure (CHF), vasculitis, uncontrolled diabetes mellitus.
- •Severe contact dermatitis (allowable if it does not interfere with application of the dressings).
- •Concomitantly receiving systemic corticosteroids in doses exceeding 20 mg per day.
- •Involvement in another experimental drug trial within the last month.
- •Clinical evidence of cellulitis or infection in or around the ulcer.
- •History of non-compliance to medical regimens and is not considered reliable.
- •Unable to understand the study evaluations and provide a written informed consent.
研究组 & 干预措施
Revera Wound Care
干预措施: Revera Wound Care (Device)
Normal Saline
干预措施: Normal Saline (Device)
结局指标
主要结局
Tabulations of AEs (Adverse Event), review of CBC (Complete Blood Count) with differential and platelet.
时间窗: CBC at initial screening and completion of dose regiment (8 weeks). AE's evaluated per protocol if and when they occur.
次要结局
- Wound edge healing rate(Weekly)
- Complete Wound Closure(Weekly)