Multicenter, open label, clinical trial on the performance and tolerability of the medical device LHAC1 (hyaluronic acid - collagenase) for the management of chronic venous ulcers

Fidia Pharmaceutical [Fidia Farmaceutici S.p.A.] (Italy)0 个研究点目标入组 100 人开始时间: 2012年2月22日最近更新: 2015年1月13日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1. Both sexes, all ethnic backgrounds, both ambulatory and hospitalized
•2. Subjects between 18 and 80 years of age
•3. Subjects with a diagnosis of chronic venous ulcers (CEAP classification: C6) with areas (or scattered areas) of necrosis (non-viable soft tissue/slough) more than 40%
•4. Subjects who have a venous leg ulcer of at least 6 months duration
•5. Subjects who have a target wound which is between 2 cm squared to 25 cm squared in area at the baseline assessment
•6. Subjects, who are, in the opinion of the Investigator, able to understand this study, cooperate with the study procedures and are willing to return to the centre for all the required visits
•7. Subjects who have given their written informed consent in accordance with provisions of pertinent excerpt from the Declaration of Helsinki (revised October 2008) and the Romanian laws

排除标准

•1. Subjects with venous leg ulcer with presence of black eschar
•2. Subjects who have exposed bone, tendon or fascia visible around the target wound
•3. Subjects who have an Ankle Brachial Pressure Index lower than 0.8 (ABPI/ABI< 0.8), measured by Doppler sonography, absent pulses and peripheral arterial disease
•4. Subjects using occlusive wound dressings. The elastocompressive bandages are allowed
•5. Concomitant use of local antibiotics, hydrogels, hydrocolloids (the administration of oral antibiotics in presence of infection is allowed)
•6. Concomitant use of detergents, hexachlorophene, acid solutions, antiseptics containing heavy metal ions (such as mercury, silver, cobalt, magnesium and manganese), or soaks containing metal ions or acidic solutions (such as Burow's aluminium acetate solution)
•7. Concomitant use of disinfectants containing quaternary ammonium
•8. Subjects with a known hypersensitivity to collagenase or hyaluronic acid
•9. Immunocompromised subjects; known seropositivity to human immunodeficiency virus (HIV)
•10. Subjects affected by severe renal, dismetabolic or hepatic failure which represents a risk to the subjects
•11. Presence of underlying medical conditions that might interfere with study completion, e.g. end-stage malignant disease, unstable diabetes mellitus, aplastic anaemia, sclerodermia, severe obesity (Body Mass Index > 35), cachexia and recent burns
•12. Participation in any other study involving investigational or marketed products concomitantly or within one month prior to study entrance
•13. A history of alcoholism, treatment abuse, psychological or other emotional problems that could invalidate informed consent or limit the subject's compliance with protocol requirements
•14. Females who are pregnant, lactating or who have not reached menopause and are not abstinent or practising an acceptable means of birth control as determined by the Investigator for the duration of the study
•15. Necessity to have a concomitant therapy with any treatment mentioned in the restrictions
•16. Subjects unlikely to be compliant/cooperative during the study, in the judgment of the Investigator

研究者

发起方

Fidia Pharmaceutical [Fidia Farmaceutici S.p.A.] (Italy)

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