A pilot randomised controlled clinical trial to compare the effectiveness of a graduated three layer straight tubular bandaging system when compared to a short stretch compression bandaging system in the management of people with venous ulceration.

Monash University0 个研究点目标入组 46 人开始时间: 2008年12月1日最近更新: 2020年1月13日

试验速览

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•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 Clinical signs, Etiologic classification, Anatomical distribution and Pathological dysfunction (CEAP) assessment 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 4 weeks
•ii.is of an area equal to or greater than 1 cm2 but less than or equal to 20 cm2 as measured by digital planimetry techniques,
•5.Ankle Brachial Pressure index of equal or greater than 0.8 mmHg.
•6.Ankle circumference of greater than 18 cm and less than 25 cm
•7.Mobile, and able to return for required treatments and study evaluations without undue hardship.
•8.Able to give Informed Consent.
•9.Able to understand and comply with the requirements of the trial.

•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.Immobility.
•4.Participation in any other clinical trial or exposure to an investigational drug within 30 days of study enrolment.
•5.Evidence of severe liver disease, cardiac disease or chronic pulmonary disease.
•6.Medical condition likely to require systemic corticosteroids during the study period.
•7.Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness).
•8.Clinically documented thrombo-phlebitis or suspected deep vein thrombosis.
•9.Unable or unwilling to attend clinic for weekly treatment
•10.Participation in this trial previously and/or who dropped out or were withdrawn.

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