Post Thrombotic Syndrome Prevention Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Villalta Score
研究概览
简要总结
This is a two arm, prospective, single center, randomized clinical trial. Subjects will be randomly assigned into one of two groups using block randomization technique in a 1:1 ratio. The control group will receive care using elastic compression stocking and the intervention group will use the ACTitouch device. Stratified randomization will occur based on whether the Deep Vein Thrombosis (DVT) has iliac or non-iliac involvement. Subjects will be followed for 2 years with clinic visits occurring at 1, 3, 6, 12, and 24 months.
详细描述
The purpose of this study is to determine if use of a pneumatic compression device (ACTitouch, Tactile Medical) is beneficial in improving or preventing the development of Post Thrombotic Syndrome (PTS). 84 patients who have a history of an acute proximal unilateral leg DVT diagnosed one or more months prior to enrollment, or diagnosed with a chronic proximal unilateral leg DVT at time of enrollment, on duplex or other imaging study will be randomized into two groups: the control group receiving the standard of care compression stockings and the intervention group receiving ACTitouch device.
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
- 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
- •At least 18 years of age or older
- •History of an acute proximal unilateral leg DVT diagnosed one or more months prior to enrollment, or diagnosed with a chronic proximal unilateral leg DVT at time of enrollment, on duplex or other imaging study (i.e MRV, CTV, venogram)
- •Current anticoagulation therapy
- •Physical ability to independently don ACTitouch or availability of help to place device
排除标准
- •Current diagnosis of PTS or PTS symptoms
- •Diagnosis of acute DVT less than 30 days prior to enrollment
- •History of prior ipsilateral DVT
- •Chronic venous insufficiency (CVI) with a CEAP 4 or greater and/or noted changes in the deep system during the diagnosing duplex
- •Morbid Obesity (BMI > 45)
- •Congestive heart failure with symptoms not controlled by medical intervention
- •Pulmonary edema, active, with symptoms not controlled by medical intervention
- •Peripheral artery disease (PAD) unless the patient has an ankle pressure of 60mmHg or more
- •Walking disability (immobile)
- •Women who are pregnant or trying to become pregnant
- •Any other condition in which compression would be contraindicated as determined by the treating physician
研究组 & 干预措施
ACTitouch - ACT-Adaptive Compression Therapy
a dual treatment pneumatic compression device offering two operational modes: sustained compression mode and intermittent compression mode. The device is applied to the lower leg (calf, ankle, and foot) and consists of an under-sock worn against the skin, a compression sleeve containing 4 inflatable chambers and a controller unit. The controller provides the airflow to inflate the chambers and monitors and adjusts the chamber pressure to maintain the intended treatment pressures.
干预措施: ACTitouch (Device)
Standard Compression Stocking
The control group will receive care using elastic compression stocking.
干预措施: Compression garments (stockings) (Device)
结局指标
主要结局
Villalta Score
时间窗: 2 Years
The Villalta score is a disease score specific for PTS. It can be used to both diagnose and categorize the severity of the condition. It was developed in a cross-sectional study of 100 patients who were assessed 6 to 36 months after DVT. * PTS not present: 0 to 4 * Mild PTS: 5 to 9 * Moderate PTS: 10 to 14 * Severe PTS: \>15
次要结局
未报告次要终点