EUCTR2010-023426-20-DE进行中（未招募）不适用
ow dose Urokinase therapy in patients with diabetic foot syndrome, critical limb ischemia as well as rest ischemia or missing of option revascularisation in comparison to the standard therapy - randomized, open, controlled phase III - AUGUST-2
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GWT-TUD GmbH
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
- •Patients = 18 years with diabetes and angiopathic or angioneuropathic diabetic foot syndrome with critical limb ischemia (at least Wagner-Armstrong stage 2C)
- •Additional inclusion criteria:
- •No revascularization possible or rest ischemia after revascularization (ALP with
- •collateral curve, to post-stenosis curve or dumb curve or ABI <0.9 or Doppler
- •trace with character of stenosis or missing, TcPO2 <30 mmHg)
- •Persistent ulcerations in spite of anti-biosis, blood glucose adjustment and
- •wound debridement
- •Expected further in-patient stay of at least 3 weeks (antibiotic therapy as well as
- •decompression)
- •Fibrinogen = 4.0 g/ll
- •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 161
排除标准
- •prospective life expectancy <1 year
- •former major amputation
- •treatment strategy major amputation after interdisciplinary treatment team
- •pre-treatment of the current episode of the diabetic foot syndrome with Urokinase (permitted in connection with the revascularization with the distance to the randomization then being minimally 7 days)
- •mechanical heart valve replacement
- •cerebral event with CT-alteration within the last 3 months
- •non-cured, proliferative retinopathy
- •uncontrollable hypertension (syst. RR > 80 mmHg, diast. RR >100 mmHg
- •hemorrhagic diathesis (spontaneous-Quick <50%, spontaneous-PTT > 40 s,
- •platelets <100 Gpt/l)
- •gastrointestinal bleeding or ulcers during the last 4 weeks
- •reverse bypass operation
- •existence of other contra-indications for a Urokinase therapy according to the
- •current specialized information
- •concurrent participation in another clinical study
- •lacking compliance
研究者
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ow dose Urokinase therapy by patients with diabetic foot syndrom and critical limb ischemia versus conventionel standard therapy. A randomised, open, controlled Phase III-study. - Urokinase in diabetic foot syndromePatients with angiopathic or angioaneuropathic diabetic foot syndrome and critical limb ischemia without the possibility of surgical or interventional revascularisationMedDRA version: 9.1Level: LLTClassification code 10012664Term: Diabetic foot ulcerEUCTR2007-005916-15-DEmedac Gesellschaft für klinische Spezialpräparate mbH200
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