Freeze-dried Amniotic Membrane in the Treatment of Non-healing Wounds: a Single-arm, Retrospectivelyprospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Non-healing wounds measuring
研究概览
简要总结
This is retrospectively-prospective clinical trial with medical device AMNIODERM+ intended for the non-healing wounds. Retrospective data will contain information about the subject's history and wound treatment by SoC. Prospective data will contain information about wound treatment by AMNIODERM+®.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Males and females over 18 years of age
- •Type 1 or Type 2 diabetes mellitus
- •Presence of a diabetic neuropathic or neuroischemic wound, anywhere on the leg, that has not healed at least 20% after the 6 weeks of the standard of care (SoC)
- •History of an evaluable defect ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion
- •Size of a wound to be evaluated 2 to 16 cm2
- •Wound treatment can be provided either on an inpatient or outpatient basis, based on the doctor's decision
- •The subject agrees to periodic visits to the clinical trial site during their participation in the clinical trial
- •The subject is able to understand the clinical trial information
- •Signed informed consent form
- •Data on previous wound care are available in the subject medical documentation
排除标准
- •Necrotic wound requiring surgical treatment
- •Pregnancy or breastfeeding
- •Venous etiology of ulceration
- •Burns or chemical burns
- •Clinical manifestations of systemic infection
- •Undermined wound edges
- •The wound involves deeper structures (bone, tendons, joints)
- •Inadequately controlled diabetes mellitus with HbA1c > 12 % (DCCT) diabetes mellitus
- •Renal insufficiency with eGF < 30ml/min/1.73m2
- •Infected ulceration either Stage ≥2 according to EWMA Position Document (2006) (Appendix II) or with CRP >10
- •Topical treatment with any growth factor-based products
结局指标
主要结局
Non-healing wounds measuring
时间窗: 6 + 12 weeks
Analyses of primary and secondary endpoints: The error rate During data collection, a change was made to the CIP regarding complete wound closure (wound heal). Whether a wound was healed was determined by the opinion of the investigator and not by the size of the wound as measured by Imito® application. The error rate of the Imito® measuring application in determining the size of the wound was 10 %, i.e. based on that and clinical experience the threshold of 0.1 cm2 was determined. Wounds smaller than or equal to 0.1 cm2 were considered as complete closure. The investigator confirmed the wound closure in an accompanying comment in the eCRF.
次要结局
未报告次要终点