ISRCTN71239043已完成未知
A double blind randomized study to assess the role of Bionect Start for the management of chronic venous ulcers
Fidia Pharmaceuticals (Fidia Farmaceutici S.p.A.) (Italy)0 个研究点目标入组 113 人开始时间: 2014年12月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 113
研究概览
简要总结
2017 results in https://pubmed.ncbi.nlm.nih.gov/28387882/ (added 17/12/2020)
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 Subjects, between 18 and 80 years of age
- •2. Subjects with a diagnosis of chronic venous ulcers (CEAP classification: C6) with devitalized/fibrinous/slough tissue more than 40% of the lesion. Chronic ulcer is defined as that ulcer not reducing its area of at least 20-40% in 4 weeks of optimum treatment (i.e. compession bandaging/stocking).
- •3. Subjects who have a venous leg ulcer of at least 6 months duration
- •4. Subjects who have a target wound which is between 5 cm squared to 30 cm squared in area at the baseline assessment
- •5. 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 center for all the required visits
- •6. Subjects who have given their written informed consent in accordance with provisions of pertinent excerpt from the Declaration of Helsinki (revised October 2008) and GCP for medical devices
排除标准
- •1. Subjects who have exposed bone, tendon or fascia visible around the target wound
- •2. Subjects who have an Ankle Brachial Pressure Index lower than 0.8 (ABPI < 0.8) measured by Doppler sonography, absent pulses and peripheral arterial disease
- •3. Concomitant use of local antibiotics, hydrogels, hydrocolloids (it is allowed the administration of oral antibiotics in presence of infection)
- •4. 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). Concomitant use of disinfectants containing quaternary ammonium
- •5. Subjects with a known hypersensitivity to Collagenase or Hyaluronic acid.
- •6. Immunocompromised Subjects; known seropositivity to HIV virus
- •7. Subjects affected by severe renal, dismetabolic or hepatic failure which represents a risk to the Subjects; presence of underlying medical conditions that might interfere with study completion, e.g. end-stage malignant disease, unstable diabetes mellitus, aplastic anemia, sclerodermia, severe obesity (Body Mass Index > 35), cachexia and recent burns
- •8. Participation in any other study involving investigational or marketed products concomitantly or within one month prior to study entrance
- •9. A history of alcoholism, treatment abuse, psychological or other emotional problems that could invalidate informed consent or limit the Subject compliance with protocol requirements.
- •10. 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
- •11. Necessity to have a concomitant therapy with any treatment mentioned in the restrictions
- •12. Subjects unlikely to be compliant/cooperative during the study, in the judgment of the Investigator
研究者
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