RBR-3y78y4招募中未知
Multicenter, Open, Randomized, Controlled Trial to Compare the Efficacy of 3M™ Coban™ 2 Lite Two Layer Compression System to the Unna Boot in Patients with Venous Leg Ulcers
Escola de Enfermagem da Universidade Federal de MInas Gerais0 个研究点开始时间: 2019年6月25日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 —（—）
入选标准
- •Male or female, aged 18 years or older; Ability to walk, either independently or with the aid of a walker; Active venous leg ulceration. If multiple eligible ulcers are present in the same leg, a single ulcer of the study leg that is up 2cm apart from any other ulcer should be selected. If eligible ulcers are on both legs, the investigator will determine which ulcer to choose as the indexed ulcer; Ulcer size between 5 cm2 and 200 cm2; Ulcer present for major 4 weeks and minor 52 weeks at the time of the screening visit; Visible edema in the leg with the selected ulcer; ABI up 0.8 and minor 1.3. ABI assessment performed within the 3 months prior to enrolment is acceptable; Provided written informed consent, including permission to take photographs of the study leg, including the wound; Ability to understand the study procedures and to complete the questionnaires; Women of childbearing potential should be sexually inactive or should use one of the following acceptable contraceptive methods (and continue to use it for at least 30 days after the end of the study; Stable hormonal contraceptive for at least 3 months prior to the study;Barrier method (preservative or diaphragm) with spermicide for at least 7 days prior to the screening visit; IUD placed at least 3 months prior to the study.
- •Women that are not of childbearing potential should be either surgically sterile (surgical bilateral tubal ligation at least 6 months prior to the study, hysterectomy or bilateral oophorectomy at least 3 months prior to the study), or be post-menopausal for over 2 years.
排除标准
- •Severe arterial occlusive disease; Decompensated heart failure (New York Heart Association {NYHA} Class IV); Severe deep vein thrombosis (phlegmasia cerulea dolens) and other conditions contraindicated according to established guidelines and local procedures; Known hypersensitivity to any of the component materials, including isocyanates and synthetic rubber adhesives; Suspected clinical infection of the ulcer or any other systemic infection (requiring antibiotics); Planned or expected surgery for the ulcer during the 12 weeks following inclusion; Hospital stay planned for the 12 weeks following inclusion; Suspected or confirmed cancerous ulceration; Participation in any other prospective study interfering with this study; Any medical condition, which according to investigator’s clinical judgement, disqualifies the subject from enrollment into the study. Diabetic subjects are eligible if they are considered clinically under control or well-controlled; Autoimmune disease with use of systemic corticosteroids for more than 1 month (patients with auto-immune disease without use of systemic corticosteroids can be included). History of noncompliance to therapies; Severe impairment of the lymphatic system with severe deformation of the leg; Cardiomyopathy - diagnosis at screening; Dialytic chronic renal failure; Pregnancy;
- •Undergoing radiotherapy and chemotherapy.
研究者
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