A Post-Marketing Surveillance to Observe the Safety and Efficacy of Dehydrated Human Amnion/Chorion Membrane (DHACM) Wound Graft in the Management of Non-Ischemic Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 10
- 主要终点
- Efficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks
研究概览
简要总结
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
详细描述
The study will enroll 75 subjects diagnosed with intractable diabetic foot ulcers or venous leg ulcers at 5 plastic surgery sites in Japan. Subjects will be treated with weekly applications of EPIFIX for up to 12 weeks, followed by 6 months of follow-up.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with intractable diabetic foot ulcers or venous leg ulcers that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies, such as radical wound management (removal of necrotic tissue, infection control, wound cleansing, etc.), glycemic control for diabetic foot ulcers, compression therapy for venous stasis ulcers and moist therapy using wound dressing materials.
排除标准
- •Areas of active infection or latent infection.
- •Patients with disorders that would cause an intolerable risk of postoperative complications.
- •Ulcers that cannot be sufficiently debrided.
- •Ulcers that, after debridement, have blood flow disorders where wound bed necrosis progresses at an early stage.
- •Wound surfaces with multiple ulcer surfaces and exposed bone, and no blood flow in the wound bed.
- •Patients with hypersensitivity to the aminoglycoside antibiotics used during manufacturing.
结局指标
主要结局
Efficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks
时间窗: 4 weeks, 8 weeks, and 12 weeks after initial application
The percentage of patients to achieve wound closure at 4 weeks, 8 weeks, and 12 weeks after initial DHACM application, as a measure of healing rate.
Safety Endpoint: Incidence of Adverse Events
时间窗: 9 months after initial application
Incidence rate of adverse events in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up.
次要结局
未报告次要终点