ISRCTN15487707已完成未知
A confirmatory multicentre, multinational, prospective, parallel-group, randomized, double-blind clinical investigation of the performance and safety of Ialuset® cream versus neutral comparator cream in the treatment of chronic, venous or mixed origin leg ulcer
IBSA Institut Biochimique (Switzerland)0 个研究点目标入组 170 人开始时间: 2020年11月23日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 170
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/35025757 (added 14/03/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult male and female (aged =18 years)
- •2. Subject diagnosed with a leg ulcer >2 months and <4 years duration
- •3. Subject diagnosed with one or several leg ulcers of mere venous (varicose or post-thrombotic) origin, or of mixed venous and arterial origin with predominance of venous aetiology
- •4. Presence of an ulcer that was intended to be treated with a surface area =5 cm² and =40 cm²
- •5. Subject having undergone an arterial-venous Doppler examination within 6 months prior to inclusion, showing a superficial or profound reflux in the venous system, and/or a well-documented past history of deep venous thrombosis of the lower limbs, and/or clinical evidence of post-thrombotic syndrome with chronic oedema and lipodermatosclerosis
- •Ankle/brachial Doppler systolic pressure index =0.8 and =1.2 within 6 months prior to inclusion
- •6. Patient whose leg ulcer compression system was adapted and worn during the study
- •7. Subject having an albuminemia =25 g/l (measured =2 weeks prior to inclusion)
- •8. Female subjects of childbearing potential having a negative urine pregnancy test result at screening and at the randomisation visit, and practising two reliable methods of contraception throughout the study
- •9. Subject having a satisfactorily general condition and a life expectancy longer than the duration of the study, according to the Investigator
- •10. Having signed a written informed consent to participate in the study, according to GCP
- •11. For France: subjects covered by a health insurance system/policy
排除标准
- •1. Subject with an ulcer of non-venous origin (e.g., phagedenic pyodermatitis, pyoderma gangrenosum, neoplastic or infectious origin) or related to a general cause (e.g., haematological cause).
- •2. Presence of necrotic tissue =50% of the target ulcer surface area
- •3. Subject with clinical evidence of a significant arterial insufficiency (claudication, pain of decubitus ulcers), and/or Ankle-Brachial Pressure Index (ABPI) <0.8 or >1.2
- •4. Subject with any type of diabetes mellitus, as per medical records (i.e. glycated haemoglobin – HbA1c <6.5%) or investigator judgment. (Note: HbA1c <6.5% was a typographical error and the investigators were told to interpret that as HbA1c >6.5%. This error was present in CIP v1.0, 24Feb2017, CRF v3.0, 11Aug2017)
- •5. Subject suffering from severe hepatic disorders (with serum activity of ALT/AST =2.5 UNL)
- •or severe renal disorders (creatinine clearance <30 ml/min) identified within 3 months prior to inclusion
- •6. Subject with a clinical suspicion of wound infection (e.g., erysipelas, phlegmon) based on the presence of at least one of the following symptoms: peri-ulcerous inflammation, odorous and purulent flow, adenopathy, lymphangitis, fever, unexpected healing interruption, or abscess.
- •7. Ulcer with exposed tendon or bone
- •8. Ulcer due to local or extended malignancy
- •9. An episode of acute deep vein thrombosis (DVT) within 3 months prior to inclusion
- •10. Subject under treatment with drugs known to adversely affect the healing process: i.e., systemic corticosteroids, cytostatic drugs, immunosuppressive agents
研究者
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