ACTRN12618001186246招募中4 期
Metformin for treating peripheral artery disease-related walking impairment
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. PAD diagnosed by a vascular specialist based on current guidelines including PAD symptoms and absence of lower limb pulses or resting ABPI <0.9 or >1.4, or imaging evidence of lower limb arterial stenosis or occlusion;
- •2. Able to walk independently, with or without walking aids, but walking limited by intermittent claudication based on history and assessment by experienced observer during a six minute walk test;
- •3. No currently planned peripheral vascular intervention;
- •4. No contraindications to metformin, including renal impairment (defined as estimated glomerular filtration rate <45ml/min/1.73m2) and severe heart failure requiring in-patient treatment within the last 12 months or leading to shortness of breath at rest.
排除标准
- •1. Asymptomatic PAD;
- •2. Patients currently involved in an exercise program for treating PAD;
- •3. Patients with severe PAD, such as rest pain or gangrene requiring urgent vascular intervention;
- •4. Previous major lower limb amputation;
- •5. Diabetes defined by Haemoglobin A1C (HbA1c) equal or greater than 6.5%.
- •6. Terminal illness making it unlikely the patient will survive 6 months;
- •7. Involvement in any other drug trial;
- •8. Clinical concern from the treating physician that the patient is not suitable for the trial.
研究者
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