ACTRN12608000060347终止2 期
A Phase IIb/III, Randomised, Multi Centre Study to Evaluate the Efficacy and Safety of MD 920 (Gibberellic Acid and Salt 1:1) Adsorbed to a Non Adhesive Dressing Used with Standard 4 Layered Compression Therapy Compared with Standard 4 Layered Compression Therapy alone in Participants with Hard to Heal Chronic Venous Ulceration
AUS BIO Ltd0 个研究点目标入组 158 人开始时间: 2008年1月31日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 158
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- All
入选标准
- •Male and female study participants who meet all of the following criteria can be entered into the study:
- •1.Presence of a venous ulcer that is confirmed by a venous duplex scan (performed by an experienced vascular technologist or ultrasonographer) to be the result of chronic venous insufficiency.
- •2.Aged over 18 years.
- •3.Present with clinical evidence of chronic venous insufficiency and chronic venous ulceration as evidenced by one or more of the following:
- •i. lower limb pigmentation,
- •ii.varicose eczema,
- •iii.lipodermatosclerosis,
- •iv. varicose veins.
- •4.Chronic venous leg ulcer (target ulcer) that
- •i.Has been present for at least 6 weeks but no longer than 52 weeks,
- •ii.is of an area equal to or greater than 3 cm2 but less than or equal to 20 cm2 as measured by digital planimetry techniques,
- •iii.has no evidence of malignancy,
- •iv.has no other aetiological factors, e.g. neuropathic, arterial, or vasculitic.
- •5.Clear of cardiac abnormalities evidenced by a normal ECG reading.
- •6.Ankle Brachial Pressure index of equal or greater than 0.8 mmHg.
- •7.Ankle circumference of greater than 18 cm and less than 25 cm (Profore® bandaging guidelines).
- •8.Mobile, and able to return for required treatments and study evaluations without undue hardship.
- •9.Able to give Informed Consent. A reasonable attempt will be made to provide a translator to those who are unable to speak and read English fluently.
- •10.Able to understand and comply with the requirements of the trial.
- •11.Female study participants of child bearing potential who have a negative pregnancy test.
排除标准
- •Study participants who meet any of the following criteria will not be eligible for participation in this study:
- •1.Unable or unwilling to wear compression bandage as directed.
- •2.Allergy to any of the trial products used.
- •3.Prior adverse reaction to compression products.
- •4.Immobility.
- •5.Ankle circumference < 18 cm or > 25 cm (Profore® bandaging guidelines).
- •6.Participation in any other clinical trial or exposure to an investigational drug within 30 days of study enrolment.
- •7.Evidence of severe liver disease, cardiac disease or chronic pulmonary disease.
- •8.History of immunologically mediated disease (for example inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus).
- •9.Medical condition likely to require systemic corticosteroids during the study period.
- •10.Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness).
- •11.Presence of malignant disease or documented history of malignant disease excluding dermatological malignancy (study participants with a five year disease free interval may be considered at the discretion of the Investigator).
- •12.Clinically documented thrombo-phlebitis or suspected deep vein thrombosis.
- •13.Abnormal laboratory results deemed clinically significant by the Investigator.
- •14.Unable or unwilling to attend clinic for weekly treatment
- •15.Participation in this trial previously and/or who dropped out or were withdrawn
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