EUCTR2006-001855-37-FR进行中（未招募）1 期
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 solution. A randomised, double-blind, controlled, parallel-group, multicentre, multinational Phase IIIb study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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 a least 2 of the following 9 infection criteria (according to Cutting and White 2005)
- •°cellulitis
- •°discharge: (increased) serous exudate with inflammation, seropurulent, heamopurulent, pus
- •°discoloration: dull brick red (beta-heamolytic Streptoccoci), blue/gree (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 >= 4 weeks and <= 1 year
- •d) surface area of the target venous ulcer (after debridement) >= 2 cm2 <= 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 the target ulcer < 4 weeks and > 1 year
- •2. Contraindications relating to local wound therapy with local antimicrobial agents (e.g. inflammation requiring systemic antibiotic therapy, malignant ulcer)
- •3. Contraindications relating to compression therapy with bandages (e.g. progressive peripheral 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, bioenginnered tissue, biophysical modalites
- •6. Previous or concomitant therapy with non-permitted local or systemic drug therapy
- •7. Indication for non-permitted wound dressings
- •8. General exclusion criteria such as 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 to the same study-, known to be or suspected of being unable to comply with the protocol (e.g. no permanent address, history of and/or 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 with understanding the language in which the patient information is given.
研究者
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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 availableEUCTR2006-001855-37-HUSchülke & Mayr GmbH240
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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 availableChronic leg ulcersMedDRA version: 9.1Level: LLTClassification code 10066677Term: Chronic leg ulcerEUCTR2006-001855-37-GBSchülke & Mayr GmbH240
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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 availableChronic venous leg ulcers In Germany, approximately three million people suffer from chronic leg ulcers of various origins. These ulcers are often very painful and extremely cost-intensive diseases associated with severe reductions of the patients’ quality of life. Vascular ulcers represent 75% of all chronic ulcers in general and are divided into venous (65%) - which is the study indication - and arterial and mixed arterial-venous ulcers (10%).MedDRA version: 9.1Level: LLTClassification code 10066677Term: Chronic leg ulcerEUCTR2006-001855-37-DESchülke & Mayr GmbH240
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