EUCTR2006-001855-37-DE进行中（未招募）不适用
Effect of an octenidine-based topical antimicrobial agent (Octenisept) on wound healing of chronic venous leg ulcers: a prospective, twelve-week comparison versus local treatment with Ringer solutionA randomised, double-blind, controlled, parallel-group, multicentre, multinational Phase III b study - not available
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •1.Patients who have given their signed declaration of consent and data protection declaration
- •2.Males and females aged at least 18 years
- •3.Patients with a locally infected chronic venous leg ulcer (target ulcer) at any location below the knee joint (CVI grade C6 according to CEAP classification= trophic lesions and open ulcer) meeting all of the following criteria:
- •a) confirmed diagnosis of chronic venous insufficiency (CVI)
- •b) presence of at least 2 of the following 9 infection criteria (according to Cutting and White 2005):
- •·cellulites
- •·discharge: (increased) serous exudate with inflammation, seropurulent, haemopurulent, pus
- •·discoloration: dull brick red (beta-haemolytic streptococci), blue/green (Pseudomonas aeruginosa)
- •·friable granulation tissue which bleeds easily
- •·unexpected pain/tenderness or change in the nature of pain ·pocketing at the base of the wound
- •·bridging of the epithelium or soft tissue
- •·abnormal smell
- •c) duration of the target venous ulcer at least 4 weeks and max. 1 year
- •d) surface area of the target venous ulcer (after debridement) min. 2 cm2 and max. 20 cm2
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Duration of target ulcer < 4 weeks and > 1 year
- •2.Contraindication regarding local wound therapy with local antimicrobial agents(e.g. inflammation requiring systemic antibiotic therapy, malignant ulcer)
- •3.Contraindications regarding compression therapy with bandages (e.g. progressed peripheral arterial occlusive disease, ABI < 0.8 or > 1.3)
- •4.Known hypersensitivity to one or more of the active and/or inactive ingredients of the investigational medicinal product
- •5.Planned ulcer treatment within the treatment period after Visit 1, e.g. surgery on varicose veins (laser coagulation, sclerotherapy, stripping), skin grafting, application of cultured keratinocytes, bioengineered tissue, biophysical modalities
- •6.Previous or concomitant therapy with non-permitted local or systemic drug therapy (see list below)
- •7.Indication for non-permitted wound dressings (see below)
- •8.General exclusion criteria like severe somatopathic, neurological and/or psychiatric disease parallel participation in another study, participation in a study within less than 6 weeks prior to study entry, or previous participation in this same study, known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or (and) known drug abuse, known to be non-compliant or presenting an unstable psychiatric history)legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study, patients in custody by juridical or official order, evidence of an uncooperative attitude (non-compliance), patients who have difficulties in understanding the language in which the patient information is given.
研究者
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