NCT00998673终止2 期
Randomized Standard-of-Care-Controlled Trial of a Silica Gel Fiber (SGF) Wound Dressing in the Treatment of Chronic Venous Leg Ulcers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 121
- 试验地点
- 14
- 主要终点
- Time to healing of target ulcer, defined as the treatment period day during the weekly visit at which the surface area of the wound was noted as zero and completely healed
研究概览
简要总结
Silica Gel Fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue growth and enhanced wound healing for all types of chronic wounds. It is applied as patch and will be hold in place by a secondary dressing for maintaining the moist wound environment. The study is aimed to demonstrate superiority over a standard wound treatment for chronic venous leg ulcers. The primary efficacy variable is time to healing.
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
- •At least one chronic venous leg ulcer fulfilling all of the following criteria:
- •Size: >/= 5 cm2 and </= 40 cm2 (measured by Visitrak Wound Measurement System)
- •Duration: >/= 3 month < 5 years
- •Location: Between and including knee and ankle
- •Depth: Involving dermis, with no exposed muscle, tendon or bone. Characterized by a viable wound bed with granulation tissue
- •The etiology of the ulcer as "venous" is proven by Duplex or Doppler sonography and with ankle/brachial arterial Doppler pressure index > 0.8 (exclusion criterion for peripheral arterial disease) and < 1.3 (exclusion criterion for medial sclerosis), or with a laser Doppler value > 40
- •Treatment with active wound care agents paused for 14 days before start of study treatment
排除标准
- •Only ulcers of other than venous etiology, e.g., diabetic ulcers or ulcers resulting from electrical, chemical, or radiation insult, after contact eczema, etc.
- •History of radiotherapy to the target ulcer site
- •Signs of infection as defined by rubor, dolor, calor, tumor, functio laesa. Fever (38°C sublingual, rectal, or ear), rigors, or leukocytosis will be considered as signs of infection in the context of the general appearance of the wound
- •Target ulcer lacking any sign of granulation tissue (bradytrophic wound bed)
- •Presence of necrotic tissue
- •Presence of fistula
- •History of connective tissue disease, e.g., systemic lupus erythematodes, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
- •Uncontrolled congestive heart failure
- •Malnutrition (albumin < 2.5 g/dl; to be measured if clinical signs of malnutrition are being observed)
- •Uncontrolled diabetes (HbA1c > 8 %)
- •Previous organ transplantation
- •Active malignant disease
- •Severe rheumatoid arthritis
- •Undergoing haemodialysis
- •Active sickle cell disease
- •Patients who are immunocompromised for reasons such as therapy with corticosteroids, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes
- •Pregnant or nursing women
- •Woman of childbearing potential who are not practicing acceptable methods of birth control during the investigation period
- •Known allergy to any of the devices' constituents
结局指标
主要结局
Time to healing of target ulcer, defined as the treatment period day during the weekly visit at which the surface area of the wound was noted as zero and completely healed
时间窗: Week 12
次要结局
- Size (cm2, measured by Visitrak Wound Measurement System) of target ulcer (Absolute size measured once per week and change between assessments at weeks 0, 4, 8, and 12)(Week 12/24)
- Incidence of complete wound healing of target ulcer at 4, 8 and 12 weeks, defined as full epithelialisation of the wound with the absence of drainage(Week 4/8/12)
- Rate of recurrence of wound at end of follow-up period of 3 months(Week 24)
研究者
研究点 (14)
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