Standardized Transcutaneous Oxygen Pressure Determination in the Upper Limb: Normal Value and Chronic Limb Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- TcPO2 of the upper limb (blood pressure, measured in millimeters of mercury (mmHg)).
研究概览
简要总结
Upper limb arterial disease is a rare condition compared to lower limb arterial disease. In the lower limb, chronic limb ischemia (CLI) is characterized by an intractable pain or an ulceration present for at least 2 weeks. Guidelines recommend to use Transcutaneous Oxygen pressure (TcPO2) measurement when a CLI is suspected to establish diagnostic with a threshold of 30 mmHg when ankle and toe systolic pressure are not available.
In the upper limb, there is no guideline to define CLI. When there is a wound preventing finger pressure measurement, TcPO2 is theoretically indicated. However, there is neither standardized site to measure nor threshold value of TcPO2.
The investigators hypothesized that normal TcPO2 may be different in the upper limb and that threshold value for CLI may also be different compared to lower limb.
The investigators planned a study with two parts:
- Prospective study of normal TcPO2 value in healthy volunteers
- Retrospective analysis of patients with upper limb arterial disease to approach the TcPO2 threshold of CLI allowing healing in upper limb
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers part:
- •Inclusion Criteria:
- •healthy volunteer without upper limb arterial disease
- •absence of opposition
- •affiliated to social insurance
排除标准
- •under 18 yrs old
- •under law protection
- •pregnancy
- •Retrospective patients part:
- •Inclusion Criteria:
- •patients with a TCPO2 measurement available for the upper limb
- •patients with a follow-up of at least 3 months available
- •absence of opposition
- •affiliated to social insurance
- •Exclusion Criteria:
- •under 18 yrs old
- •under law protection
- •pregnancy
结局指标
主要结局
TcPO2 of the upper limb (blood pressure, measured in millimeters of mercury (mmHg)).
时间窗: Healthy volunteers: Enrollment. Patients: 1 month after information letter sending.
Measured on both healthy volunteers (4 sites of measure) and patients with arterial disease The measurements are carried out by non-invasive extracorporeal electrodes with CE (Conformité Européenne) marked equipment and used in accordance with the CE mark.
次要结局
- level of amputation (only for the retrospective patients)(3 months)
- ROC (Receiving Operator Characteristic) curve for critical ischemia (only for the retrospective patients)(3 months)
- revascularization (only for the retrospective patient)(3 months)
- patients characteristics (only for the retrospective patients)(3 months)
- healing (only for the retrospective patients)(3 months)
- TcPO2 of the upper limb (mmHg) (only for the healthy volunteers)(Enrollment)
- Sensitivity and specificity for critical ischemia (only for the retrospective patients)(3 months)
- healing after revascularization(3 months after revascularization)