Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Flow
研究概览
简要总结
Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.
详细描述
Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus. The microcirculation should be assessed by a combination of laserdoppler flowmetry and white light tissue spectrometry (O2C Device, Parameters sO2, Flow, rHb). By this, it is possible to detect the influence of the compression therapy on the skin microcirculation.
Therefore, three study arms should be investigated, all patients clinically suffering under leg edema: healthy volunteers, patients with mild to moderate PAD and diabetics. All patients are recieveing compression therapy (Compression stockings class I for three hours, after a short break compression stockings class II for 3 hours) under Perfusion assessment control (O2C device).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Study-Arm PAD:
- •leg edema
- •symptomatic PAD (Fontaine stage II)
- •no palpable foot pulses
- •ABI <0.9 and >0.6, absolute ankle pressure > 60mmHg
- •Study-Arm Diabetes:
- •leg edema
- •Diabetes mellitus Typ 2 (history of longer than 2 years)
- •palpable foot pulses
- •Pallaesthesie >6
- •Wagner Score 0
排除标准
- •Study-Arm PAD:
- •Critical limb ischemia
- •ABI < 0.6
- •simoultaneous Diabetes Mellitus
- •Study-Arm Diabetes:
- •Wagner Score >0
- •Pallasthesie <6
结局指标
主要结局
Flow
时间窗: 12 Months
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter Flow
Number of participants with treatment-related adverse events as assessed by questionnaire
时间窗: 12 Months
The Adverse Events are defined in the questionnaire as: Abort of the Therapy, Pressure marks, Quantification of the wearing comfort (Points 1-10), subjective reduction of the leg edema (Points 1-10)
rHb
时间窗: 12 Months
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter rHb
sO2
时间窗: 12 Months
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter sO2
次要结局
未报告次要终点
研究者
Ulrich Rother
Principal investigator PD Dr. med. Ulrich Rother
University Hospital Erlangen