Diagnostic Tools to Establish the Presence and Severity of Peripheral Arterial Disease in People With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 604
- 试验地点
- 17
- 主要终点
- Diagnostic Accuracy
研究概览
简要总结
In the UK there are over 7,000 leg amputations each year because of diabetes. The most important cause of this is poor circulation. The detection of poor circulation in patients with diabetes is difficult. A number of tests exist to detect poor circulation (known as peripheral arterial disease (PAD)). However, there is confusion as to which is the gold standard.
The DM PAD study aims to determine the diagnostic performance of index tests (audible handheld Doppler, visual handheld Doppler, ankle brachial pressure index (ABPI), exercise ABPI and toe brachial pressure index (TBPI)) for the diagnosis of PAD in patients with diabetes as determined by a reference test (CTA or MRA).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Aged ≥18 years
- •Known history of diabetes
排除标准
- •PAD status known on imaging
- •Known history of PAD intervention
- •CTA and MRA contraindications- renal impairment, pregnancy, contrast medium hypersensitivity/allergy, non-compatible implants (MRA only).
- •Unable to provide appropriate informed consent.
结局指标
主要结局
Diagnostic Accuracy
时间窗: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.
Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a Magnetic resonance angiograph (MRA) or Computed tomography angiography (CTA) (reference test).
Diagnostic Accuracy - Ratios
时间窗: 6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.
Diagnostic accuracy of the PAD-scan and other bedside tests will be compared to the results of a Magnetic resonance angiograph (MRA) or Computed tomography angiography (CTA) (reference test).
次要结局
- Health Economic Outcome - Cost Effectiveness(5 years)
- Health Economic Outcome - Cost Effectiveness (QALY)(5 years)
- Patient Acceptability(1 hour: all index tests will be performed on the same day of presentation.)
- Technical Success(6 weeks; all index tests will be performed on the same day of presentation; reference scan performed within six weeks of the index tests.)