NCT02930499暂停不适用
A Prospective, Randomized, Controlled, Longitudinal Study Using Repeated Measures Design to Evaluate a Hyaluronic Acid Extracellular Matrix (Hyalomatrix®) in the Management of Chronic Venous Ulcers
Calvary Hospital, Bronx, NY2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Effect of Hyalomatrix® plus standard care on the incidence of wound healing
研究概览
简要总结
The purpose of this pilot study is to compare the incidence and rate of wound healing in subjects with venous ulcers treated with an extracellular matrix composed of hyaluronic acid plus compression therapy as compared to standard care. The study also intends to follow the subjects for a 16-week period in order to evaluate ulcer recurrence within treatment groups.
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
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 18-85 years of age with chronic venous insufficiency (CVI) and the presence of venous ulceration for longer than 2 months
- •Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages
- •Study subject must be reliable, responsible and able to visit the clinic weekly for the full 16 week period.
排除标准
- •Ulcers of non-venous etiology
- •Subject has a known sensitivity to hyaluronic acid
- •Presence of wound infection as determined by clinical signs and symptoms
- •Subject has any evidence of peripheral arterial disease (PAD)
- •Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening date.
- •Pregnancy or lactation at time of treatment.
- •Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
- •Subject currently enrolled or participated within 30 days of baseline in another investigational device, drug or biological trial.
- •History of alcohol or drug abuse.
- •Subject allergic to a broad spectrum of primary & secondary dressing materials, including occlusive dressings and the adhesives on such dressings.
结局指标
主要结局
Effect of Hyalomatrix® plus standard care on the incidence of wound healing
时间窗: 16 weeks
次要结局
- Rate of wound healing by decrease in ulcer surface area Incidence of 50% wound healing by 4 weeks Reduced VLU recurrence after healing(16 weeks)
研究者
Oscar M. Alvarez, PhD
Director Wound Care Center
Calvary Hospital, Bronx, NY
研究点 (2)
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