Post Thrombotic Syndrome Prevention Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Deep Vein Thrombosis; Post Thrombotic Syndrome
• Intervention / Treatment: Device: ACTitouch; Device: Compression garments (stockings)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Experimental: Standard Compression Stocking; The control group will receive care using elastic compression stocking.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Villalta Score	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	2 Years

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Thomas Maldonado, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Adaptive Compression Therapy Delivery System
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Embolism and Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Syndrome; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome
• Other Study ID Numbers: 15-01178

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No