NCT03039517

Post Thrombotic Syndrome Prevention Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Thrombotic Syndrome
• Deep Vein Thrombosis

Interventions

Type	Name	Description
DEVICE	ACTitouch	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.
DEVICE	Compression garments (stockings)	Compression garments (stockings) now serve as the generally recommended standard of care for patients post DVT and will be utilized as the control compression method in this study. Compression garments utilized in this study will be "below the knee" style with a pressure range of 30-40 mmHg. If a patient does not have compression garments as indicated, these stockings will be provided.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2017-02-01
• Last updated: 2019-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study