Post Thrombotic Syndrome Prevention Study

Not Applicable

Withdrawn

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Standard Compression Stocking	Compression garments (stockings)	The control group will receive care using elastic compression stocking.
ACTitouch - ACT-Adaptive Compression Therapy	ACTitouch	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.

Primary Outcome Measures

Name	Time	Method
Villalta Score	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

Secondary Outcome Measures

Name	Time	Method

Locations (1): New York University School of Medicine
🇺🇸
New York, New York, United States

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