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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 5
- 主要终点
- Proportion of subjects with complete wound closure after 26 weeks.
研究概览
简要总结
A prospective, multicenter, randomised controlled phase II study in which patients with therapy resistant (arterio-) venous leg/foot ulcers are treated with Tiscover® (test group) or with AS210 (control group) to determine the safety and relative efficacy of both products.
详细描述
Multicenter, randomised clinical trial in out patient in which patients with chronic (arterio-) venous leg/foot ulcers are treated with an autologous cultured human living skin substitute (Tiscover®: test group) or with Acellular donor dermis (AS210: control group). During a pre-inclusion evaluation period of 4 weeks (non healing) chronicity of ulcer is ensured (ulcer size change of < 30%). To determine ulcer type ABI, Doppler and CEAP is performed.
The test group will receive 2 applications of Tiscover®. Week 0: wound activating pre-treatment, application of at least one quarter of the wound surface. Week 1: removal of patches, application of patches on total wound surface.
The control group (16 patients) will follow the same application protocol.
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
- 否
入选标准
- 未提供
排除标准
- •History of anaphylaxis, serum sickness, or erythema multiforme reaction to bovine serum proteins, gentamycin.
- •Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
- •A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
- •Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
- •Refusal of or inability to tolerate compression therapy.
- •Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
- •History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
- •>30% change of wound size in 4 weeks or confirmed by historical data
- •Presence of deep vein thrombosis 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;
- •Severe infection of ulcer, active cellulitis, osteomyelitis
- •Severe malnutrition
- •Uncontrolled diabetes mellitus, HbA1c > 12% (108 mmol/mol)
- •Anaemia Hb <6 mmol/l
研究组 & 干预措施
autologous cultured skin
autologous cultured skin patches (Tiscover) is applied on wound in 2-step procedure with 1 week interval. Dosage: number of patches depends on wound size. Application week 0 is removed after one week (week1). Week 1: wound is completely covered with new Tiscover patches.
干预措施: Tiscover (Drug)
acellular donor dermis
acellular donor dermis (AS210) is applied on wound in 2-step procedure with 1 week interval. Dosage: number of patches depends on wound size.
Application week 0 is removed after one week (week1). Week 1: wound is completely covered with new AS210 patches.
干预措施: AS210 (Other)
结局指标
主要结局
Proportion of subjects with complete wound closure after 26 weeks.
时间窗: 26 weeks
The primary objective of this study is to demonstrate the superiority of Tiscover® compared to AS210 for achieving wound healing in subjects with a chronic (arterio) venous leg or foot ulcer.
次要结局
- Time in days to complete wound closure from baseline.(12 weeks)
- • Proportion of subjects with complete wound closure at each of the 12 treatment weeks.(12 weeks)
- Percentage of wound closure(12 and 26 weeks)
- Proportion of subjects with durable wound healing over the 3 months following complete wound closure(3 months and 6 months follow up)
- Wound size reduction(12 and 26 weeks)
- Pain(week 0, 1,2,4,8,12, 26 weeks and follow up)
- Quality of Life(Week 0, 12, 26 weeks and follow up)
- Number of SAE(12, 26 weeks and follow up)
研究者
Chantal Blok
trial coordinator
Amsterdam UMC, location VUmc