EUCTR2010-021797-10-NL进行中（未招募）不适用
A phase II randomized multicenter study on efficacy and safety of cultured autologous skin (Tiscover®) and acellular dermal matrix (AS210) in chronic (arterio-)venous ulcers - Autologous Skin Substitute for leg ulcers
VU university medical center0 个研究点目标入组 49 人开始时间: 2011年11月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Presence of confirmed venous, arterio-venous.
- •Patients age over 18 years and under age of 90 years.
- •Ulcer duration over 12 weeks and less than 5 years consecutively
- •<15% ulcer size reduction in 4 weeks prior to inclusion
- •Ulcer is between 1-40 cm2 in size
- •ABPI = 0.7 and < 1.2
- •Ulcer depth < 1 cm
- •Mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations
- •(Legally) capable to give informed consent
- •Able to understand and comply with requirements of study protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 49
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 49
排除标准
- •Ulcer chronicity < 12 weeks
- •>15% increase of ulcer size in 4 weeks prior to inclusion or confirmed by historical data (patient status)
- •Presence of deep vein trombosis or contra indication for compression therapy
- •Severe co-morbidity reducing life expectance to < 1 year
- •Use of oral corticosteroids and/or cytostatics >20 mg/per day;
- •Allergies to Gentamycin (which is used in the tissue media), Clindamycin or Ciprofloxacin, or the used local wound treatments
- •Severe infection of ulcer, active cellulitis, osteomyelitis
- •Expected non-compliance with compression therapy, protocol treatment or no informed consent
- •Severe malnutrition
- •Uncontrolled diabetes mellitus, HbA1c > 12% (108 mmol/mol)
- •Anaemia Hb <6 mmol/l
- •Current participation in another clinical trial, prior participation in another trial in 3 months.
研究者
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