NCT02120755撤回4 期
A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds
Liventa Bioscience1 个研究点 分布在 1 个国家开始时间: 2014年4月23日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Reduction in Wound Size
研究概览
简要总结
This research project is testing a product called AmnioClear™ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human amniotic membrane is regulated solely under section 361 of the Public Health Service Act.
The purpose of the study is to see if this treatment works to accelerate the healing time of chronic wounds.
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
- 是
入选标准
- •Stable Type I or II diabetes mellitus
- •At least one chronic diabetic ulcer
- •Full-thickness ulcer size from 1-8 cm2.
排除标准
- •Concurrent use of corticosteroids, NSAIDs immuno-suppressive or cytotoxic agents
- •Bleeding disorders
- •Ulcer with muscle, tendon, capsule or bone involvement
结局指标
主要结局
Reduction in Wound Size
时间窗: 12 Weeks
Clinical assessment of wound healing in terms of the reduction in size and shape of the wound over time.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Study of Amniotic Membrane Graft in the Management of Diabetic Foot UlcersDiabetic FootFoot Ulcer DiabeticNCT02399826Lower Extremity Institute for Research and Therapy40
终止
不适用
Human Amniotic Membrane On Venous Leg Ulcers In an Elderly PopulationVenous Leg UlcerNCT06544564BioLab Holdings30
已完成
1 期
A Therapeutic Trial of Human Amniotic Epithelial Cells Transplantation for Primary Ovarian FailurePrimary Ovarian InsufficiencyInfertilityPremature Ovarian FailureNCT02912104International Peace Maternity and Child Health Hospital36
已完成
不适用
Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic ProstatectomyPudendal NerveNCT01832168MiMedx Group, Inc.34
已完成
1 期
Safety and Feasibility of Amniotic Fluid as a Treatment for COVID-19 PatientsSARS CoV-2NCT04497389University of Utah47