Post Thrombotic Syndrome Prevention Study

Status: Withdrawn
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
New York University School of Medicine
New York
Time Frame
Start Date: 2017-01
Completion Date: 2018-02
Treatments
Experimental: 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.
Experimental: Standard Compression Stocking
The control group will receive care using elastic compression stocking.
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov