VenUS IV: a randomised controlled trial of compression hosiery versus compression bandaging in the treatment of venous leg ulcers

niversity of York (UK)0 个研究点目标入组 489 人开始时间: 2009年3月17日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Both males and females, aged 18 years or over
•2. Patient has at least one venous leg ulcer*
•3. Patient has an ankle brachial pressure index (ABPI) equal to or greater than 0. 8 and <1.2 (taken within last 3 months)
•4. Patient is able and willing to tolerate high compression
•*For the purpose of this study a leg ulcer will be considered as any break in the skin on the leg (below the knee and above the malleoli) which as either (a) been present for more than six weeks or (b) occurs in a person with a history of venous leg ulceration. A participant will be considered to have a purely venous leg ulcer where clinically no other aetiology is suspected. Clinical history must be considered and the study participant must have an ABPI of equal to or greater than 0.8. The ulcer must also be venous in appearance (i.e. moist, shallow, irregular shape, venous eczema, ankle oedema).

•1. Leg ulcer of non-venous aetiology (i.e. arterial)
•2. Wound exudate levels too high for the use of compression hosiery (nurse judgement)
•3. Patient has very bony prominences at risk of pressure damage
•4. Patients are unable or do not wish to consent to participation in the trial
•5. Patients are currently in another study evaluating treatments for their leg ulcer
•6. Known allergy to any trial product
•7. Patient has previously been in this trial
•8. People with diabetes mellitus whose blood sugar not well controlled (HbA1c greater than 10% taken within the last three months). (Patients with well controlled diabetes HbA1c less than or equal to 10% are eligible for the trial)

发起方

niversity of York (UK)