NCT00979836暂停3 期
Randomized, Double-blind Multicenter Clinical Trial Comparing the Efficacy of Calcium Dobesilate With Placebo in the Treatment of Ulcer Secondaries to Chronic Venous Disease
Fundacion Iberoamericana Itaca42 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 230
- 试验地点
- 42
- 主要终点
- Healed venous ulcers
研究概览
简要总结
The objective of the study is to assess the efficacy of calcium dobesilate for treating chronic venous wounds.
The hypothesis is that venous ulcers treated with standards measures (compressive measures) and calcium dobesilate will heal-up better than venous ulcers treated with standards measures (compressive measures) and placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with venous ulcer (CEAP 6) that affect epidermis, dermis and/or subcutaneous tissue, with and area superior to 3 cm2
- •Ankle-arm index 0.9 or superior
- •Written informed consent of the patients
排除标准
- •Patients with venous ulcer (CEAP 6) that affect bone or with and area inferior to 3 cm2
- •Ankle-arm index inferior to 0.9
- •No written informed consent of the patients
- •Diabetes mellitus I y II
- •Patients with renal failure and dialysis
- •Vascular surgery needed
- •Impossibility to use compressive measures on the leg
- •Use of topic antibiotics, silver dressing, growth factors, plasma-rich in platelets, skin graft, pentoxifylline, ultrasounds, laser, hyperbaric oxygen, electric stimulation o vacuum.
- •Pregnancy
- •Breast feeding
- •No anticonceptives measures
- •Allergy or intolerance to phebotonics
- •Background of neutropenia or leucopenia
- •Basal leucocytes < 3.500/ml
研究组 & 干预措施
Calcium Dobesilate
Experimental
干预措施: Calcium Dobesilate (Drug)
Placebo
Placebo Comparator
The placebo is a capsule with the same presence of experimental drug.
干预措施: Calcium Dobesilate (Drug)
结局指标
主要结局
Healed venous ulcers
时间窗: at 6 months of treatment
次要结局
- Ulcer recurrence(at 12 month)
- Percentage of re-epithelization area (cm2)(at 6 month of treatment)
- Length of time to heal ulcers(during all the period of the study (12 months))
- Ulcer pain(at 6 and 12 months)
- Safety(during the study (12 months))
研究者
研究点 (42)
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