Clinical Trial: Post Thrombotic Syndrome Prevention Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Post Thrombotic Syndrome Prevention Study

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 Summary: 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). We plan to enroll 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. They will be randomized into two groups: the control group receiving the standard of care compression stockings and the intervention group receiving ACTitouch device.
Sponsor: New York University School of Medicine

Current Primary Outcome: Villalta Score [ Time Frame: 2 Years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: New York University School of Medicine

Dates:
Date Received: January 30, 2017
Date Started: January 2017
Date Completion: December 2021
Last Updated: January 30, 2017
Last Verified: January 2017