NCT03544788撤回不适用
HEAL I (The Treatment of Venous Leg Ulcers): Evaluation of Cirvo™ Mobile Compression Device for the Treatment of Venous Leg Ulcers
Radial Medical, Inc.2 个研究点 分布在 1 个国家开始时间: 2019年6月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Percent of subjects fully healed at 12 weeks
研究概览
简要总结
This study in venous leg ulcer (VLU) patients will evaluate the use of Cirvo™ therapy for the treatment of VLU when applied for a minimum of two hours daily for up to 12 weeks.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between 18 and 80 years of age
- •Patients (CEAP 6) who have not previously experienced a period of open ulceration exceeding 26 weeks in the affected leg
- •Total venous ulcer area < 20cm2
- •Duration of therapy for active venous ulcer <26 weeks prior to enrollment
- •Venous insufficiency documented by venous reflex ultrasound showing mild, moderate, or severe reflux in the superficial or deep venous system
排除标准
- •Acute DVT within the 3 months prior to enrollment
- •Ulcer present for <2 weeks
- •Ulcers extending with exposed fascia, tendon, or bone within the wound margins
- •Lateral malleolus ulcers
- •Ulcers with perforator incompetence deep to the ulceration (within 5 cm of the wound border)
- •Active infection (systemic or in the affected limb)
- •Lower extremity gangrene
- •Diabetes mellitus (Type I or II) requiring medication
- •History of pulmonary vascular disease (PVD)
- •History of pulmonary edema
- •History of decompensated congestive heart failure (CHF)
- •Open surgery or major trauma to the legs within the last six months
- •History of lower limb malignancy, primary or secondary
- •Acute symptomatic lower extremity thrombophlebitis
- •Pregnant or breastfeeding
- •Calf geometry on which Cirvo(TM) device does not appropriately fit
- •Known sensitivity to any of the materials used in the Cirvo(TM) device
- •Currently participating or plans to participate in in any other investigational clinical evaluation during the 12 week study period that may, in the opinion of the investigator, affect blood flow and/or venous leg ulcer
研究组 & 干预措施
Cirvo™ Therapy
Experimental
干预措施: Cirvo™ Therapy (Device)
结局指标
主要结局
Percent of subjects fully healed at 12 weeks
时间窗: 12 weeks
次要结局
- Percent of wound epithelialized at 12 weeks(12 weeks)
- Percent of subjects fully healed at 4 weeks(4 weeks)
研究者
研究点 (2)
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