NCT00821431已完成2 期
A Phase II Study to Compare the Effect of a Compression Device to That of a 4-layer Compression System on Subjects With Venous Leg Ulcers.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 20
- 主要终点
- Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)
研究概览
简要总结
A prospective, Phase II, stratified, randomized study to compare the safety, ulcer healing, patient compliance (concordance) and resource utilisation of a compression device with IPC mode to a Class 3(c) UK standard graduated compression regime (4- layer system) on subjects with venous leg ulcers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects over 18 years, willing and able to provide written informed consent
- •Subjects able to wear the compression device and the comparative regime and follow the requirements of the clinical investigation plan
- •Subjects who had an ankle to brachial pressure index (ABPI) of 0.8 or greater
- •Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) 2 cm2 in size or greater, who required graduated compression
- •Subjects who were outpatients
排除标准
- •Subjects with a history of skin sensitivity to any of the components of the study product, comparator product or standard dressings
- •*Subjects with more than one ulcer on the test leg
- •Subjects who had previously been entered into the study or a previous Amadeus study (U327, U332 or U337) or had participated in a previous clinical study within the past 3 months
- •Subjects with any condition that prevented application and removal of the device without external assistance
- •Subjects who had an active Deep Vein Thrombosis (DVT) or a recent DVT within the last 3 months
- •Subjects who exhibited any other medical condition which, according to the Investigator, justified the subject's exclusion from the study
- •Subjects who had leg sizes outside the following range:
- •Ankle - 12cm to 44cm
- •Calf - 22cm to 60cm
- •Below knee - 22cm to 68cm
- •Subjects who had an index venous leg ulcer greater in size than 10cm in any one dimension
- •Diabetic subjects with advanced small vessel disease
- •Denotes the exclusion criterion was amended and approved by the Ethics Committees as follows:
- •Amendment #1 dated 27th March 2007:
- •*Diabetic subjects who, in the opinion of the investigator, were not in reasonable metabolic control or had a history of hospitalisation within the last six months for the management of blood sugar and/or diabetic subjects with advanced small vessel disease
- •Amendment #2 dated 2nd August 2007:
- •*Subjects who had an index venous leg ulcer greater in size than 15cm in any one dimension
- •Amendment #3 dated 5th October 2007:
- •Deletion of exclusion criterion 'Subjects with more than one ulcer on the test leg' to permit inclusion of subjects with multiple ulcers on the test leg
结局指标
主要结局
Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)
时间窗: 12 Weeks
次要结局
- Healing Measured by Number of Subjects Healed During the 12 Week Study Period(12 weeks)
研究者
研究点 (20)
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