NCT01238419已完成4 期
Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 63
- 主要终点
- pain at dressing removal
研究概览
简要总结
The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer.
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
- •Patient of either sex over 18 who have not been declared legally incompetent and who having given his written informed consent
- •Patient with venous or predominantly venous leg ulcer (ankle-brachial index > 0.8)
- •Patient with venous or predominantly venous leg ulcer in granulation phase (granulation tissue > 70 %)
- •Patient with venous or predominantly venous leg ulcer with low exsudate
- •Patient with venous or predominantly venous leg ulcer with a wound surface between 4 cm² and 170 cm²
- •Patient with venous or predominantly venous leg ulcer that has been treated with an appropriate compression in the two weeks prior to inclusion
- •Patient available to be monitored for at least 4 weeks
- •Patient able to answer questionnaires and particularly to evaluate his pain
排除标准
- •Patient whose leg ulcer is locally infected (At least 3 of 5 clinical signs suggestive of infection *)* 5 signs suggestive of infection: pain, exsudate, smell, oedema, erythema
- •Patient requiring an analgesic treatment for the care (before dressing removal)
- •Patient whose ulcer belongs to angiodermatitis type or demonstrates a vasculitis
- •Patient with arterial ulcer
- •Patient with purely traumatic, infectious or neoplastic origin ulcer
- •Patient with a diabetic neuropathy of lower limbs
- •Patient with a known allergy to one of Physiotulle or Urgotul components
- •Patient already participating in another clinical study
- •Pregnant or breastfeeding patient
- •Patient who have been taking corticoids > 10mg / day or cytostatics by systematic way for the three months prior to inclusion
- •Patient who have undergone surgery of saphenous trunk in the two months prior to inclusion
结局指标
主要结局
pain at dressing removal
时间窗: 4 weeks
pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale
次要结局
- Relative reduction of the area of the leg ulcer measured by planimetry at final point at week 4 compared to the area at inclusion(4weeks)
- Number of patients with adverse events as a measure of safety and tolerability(4 weeks)
研究者
研究点 (63)
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