Triple-Blind Clinical Trial With Placebo Control to Evaluate the Efficacy of a Heparin of Low Molecular Weight (Bemiparin) for Treating Slow-Responding Ulcers in Diabetic Foot in Primary Care
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 84
- 主要终点
- Ulcer area
研究概览
简要总结
To assess the efficacy of bemiparin (low molecular weight heparin) for 3 months in the treatment of chronic foot ulcers in diabetic patients.
详细描述
The involvement of microcirculation in diabetes microangiopathy may be the cause of ulceration and severe incapacitation. Torpid ulcers of the lower limbs affect up to 15% of diabetic patients at some moment of their lifetime; about one-third of patients developing ulcers will never achieve their definitive cure, and half of them will die within three years .
Heparins, besides their well known antithrombotic effects, have been shown to stimulate both the synthesis of heparan sulphate -a potent endogenous anticoagulant- in endothelial cell cultures and the proliferation of fibroblasts taken from diabetic ulcers .
After noticing the highly positive evolution of chronic ulcers in six diabetic patients who had received LMWHs in their homes for the prophylaxis of deep vein thrombosis , and considering the excellent safety record of these drugs, we decided to explore the effects of LMWHs on the evolution of diabetic foot ulcers and the quality of life of diabetic patients seen in our primary care practices.
Comparison: bemiparin vs 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
- Double
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
- •age over 18 years;
- •type I or II diabetes mellitus diagnosed (ADA 1998) for more than 3 years;
- •presence of at least one cutaneous ulcer distal to the knee, not involving deep tissues (stages I and II of Wagner's classification ) and existing for at least three months;
- •giving their written informed consent.
排除标准
- •hypersensibility to heparin or pig derivatives
- •body weight lower than 35 kg
- •presence of clinical signs of infection that did not resolve in spite of oral antibiotics;
- •anticoagulant therapy;
- •severe impairment of renal or hepatic function;
- •bleeding disorder;
- •active peptic ulcer;
- •arterial hypertension with poor control;
- •pregnancy or lactation;
- •terminal illness or a prognosis of survival under three months.
结局指标
主要结局
Ulcer area
Stage in Wagner's classification
次要结局
- Adverse effects
- Quality of life