EUCTR2013-003104-39-CZ进行中（未招募）1 期
Randomised Clinical Study of Safety of Efficacy of Extracelular Matrix and Autologous Platelet Rich Plasma Concentrate for Wound Healing(Leg Ulcers Biodesign Wound Healing – LEGEND(A) Study)Investigators Initiated study - LEGEND(A) Study
Fakultní nemocnice Ostrava,Czech republic0 个研究点目标入组 90 人开始时间: 2013年7月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •Patient meets one or more diagnostic criterias:
- •- Diabetes mellitus Typ I or Type II
- •- Chronic Venous Insufficiency
- •Patients with chronic wounds meets all of this criterias:
- •- Time of chronic wound occurrence is between 12 an 52 weeks
- •- Wound is crossing dermis into subcutaneous tissue
- •- Area diameter is less then 40cm2 in the largest area measurred by Adobe Photoshop software
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •General exclusion criterias:
- •- Age under 18 Y at the time of the treatment
- •- Pregnant patients or women planning the pregnancy in the period of study run.
- •- Patients enrolled in the other study
- •- Patients wo didn't signed informed consent or are anaible for the the FU controls
- •Eclusion criterias under clinical status:
- •- patients with haemostatic problems after the first necrotic tissue debridment
- •- the diameter of the wound had diminished in more then 30% after screening period before study enrollement time.
- •- wound is penetrating the bone area
- •- Wound dressing change is necessary more the 2 times per week
- •- Ancle brachial index -ABI < 0,5 for CLI
- •- albuminu < 2,5 g/dl or prealbuminu < 5,0 g/dL
- •- Hgb A1c > 12% of level
- •- Wound infection
- •- Osteomyelitis
- •- Celulitis
- •- Legg gangrene
- •- Necrotis or avascular ischemic wound basement layer
- •- Swelling > scale 2+
- •- Hyperbaroxic therapy in the last 7 days
- •- Local antibiotics, antiseptic or enzymatic therapy in the last 7 days
- •- Aplication of the KGF,TGF or other growth factors localy in the last 30 days
- •- Bone or tendon procedures in the last 30 days
- •- revascularisation procedure in the last 60 days on the target legg
- •- Malignancy in the place of the wound
- •- Radiation therapy of the wound are around 6 cm
- •- Organ transplantation in the patients history
- •- Haemocoagulation disease
- •- Vasculitis
- •- Lymphedema
- •- Cirrhosis
- •- Charcott legg deformity
- •- Hairy cell anemia
- •- Alergy on local anesthetics
- •- Alergy on pig products
- •- Haemodialysis
- •- Chemotherapy
- •- Local steroid therapy (>10 mg of prednison/day)
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