NCT02104180已完成不适用
Evaluation of the Non-inferiority of TulleGras M.S.® Versus Urgotul® in Pain Associated With Removal of Wound Dressing During Care of Venous Leg Ulcer. An Open-label, Multicenter, Randomized, Controlled, Crossover Study With Blinded Reading of Healing Criteria.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 62
- 试验地点
- 54
- 主要终点
- Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal
研究概览
简要总结
Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject informed of the objectives, purpose, details and constraints of the study and who has given his/her written informed consent.
- •Male or female subject.
- •Subject at least 45 years of age.
- •Subject presenting with an open venous leg ulcer.
- •Age of venous leg ulcer between 1 month and 12 months inclusive at the Inclusion Visit (Visit 1).
- •Venous leg ulcer whose area is between 4 cm2 and 50 cm2 inclusive at the Inclusion Visit (Visit 1).
- •Venous leg ulcer in the granulation phase over 50% of its area at the Inclusion Visit (Visit 1);
排除标准
- •Related to the disease studied:
- •Venous leg ulcer for which surgery is indicated or for which a surgical procedure is planned within twelve weeks of inclusion in the study (Visit 1).
- •Venous leg ulcer at start of cleaning phase;
- •Fibrinous and dry ulcer (non exudative wound) or on the contrary highly exudative and/or hemorrhagic.
- •Venous leg ulcer with signs of critical colonization or clinically infected.
- •Cancerous venous leg ulcer.
- •Related to the subject:
- •Subject presenting with a serious systemic disease, which may lead to premature termination of the study before the end of the twelve weeks of treatment of the Follow up Period.
- •Subject with a medical history or a significant disease revealed by history which can limit his/her participation or prevent the subject from completing the study.
- •Subject presenting with a progressive neoplasm, treated with radiotherapy or chemotherapy or immunosuppressant therapy or high-dose corticosteroids.
- •Subject who underwent surgery directly related to his/her venous disease during the two months prior to Inclusion Visit (Visit 1).
- •Subject with poorly controlled diabetes.
- •Subject who presented with a deep venous thrombosis during the 3 months prior to Inclusion Visit (Visit 1).
- •Subject confined to bed.
- •Woman of child-bearing potential (NOT postmenopausal for at least 24 months or NOT surgically sterilized (tubal ligation) or NOT hysterectomized) who is NOT routinely using adequate and efficient hormonal contraception or barrier method (intrauterine device, diaphragm, combination of condom and spermicide) prior to and during the trial.
- •Subject whose ankle has a circumference, measured at the Inclusion Visit (Visit 1), greater than 32 cm (> 32 cm).
- •Subject presenting with symptomatic or asymptomatic peripheral arterial disease, particularly with a distal systolic pressure index, measured at the Inclusion Visit (Visit 1), ≤0.8 or ≥1.
- •Subject with a history of allergic reaction(s) to one of the different components of the dressings or with a contra-indication to the use of one of these dressings.
- •Known history of alcohol abuse or drug abuse.
- •Subject linguistically or psychologically unable to understand the information given and to provide informed consent.
- •Subject participating in or who participated in another clinical study within 4 weeks prior to the Inclusion Visit (Visit 1).
- •Subject not covered by or not a beneficiary of the Social Security system.
- •Subject deprived of his freedom as the result of a legal or administrative decision or subject to legal guardianship.
- •Any other reason, in the investigator's opinion, that prohibits the inclusion of the subject into the study.
结局指标
主要结局
Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal
时间窗: at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)
Pain intensity experienced by subjects associated to removal of each study primary dressings during the care, assessed at of the Cross-over Period on a visual analogue scale (VAS). The VAS was provided as a 100 mm, non-graduated horizontal line, with extremities indicating " no pain " (0) and " extreme pain " (100). The subject responded by drawing a vertical line to assess the pain intensity he/she experienced at the time of removal of the primary wound dressing.
次要结局
未报告次要终点
研究者
研究点 (54)
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