Post Thrombotic Syndrome Prevention Study

Deep Vein Thrombosis Clinical Trial

Official title:

Post Thrombotic Syndrome Prevention Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03039517
• Other study ID #: 15-01178
• Status: Withdrawn
• Phase: N/A
• Start date: January 2017
• Est. completion date: February 2018

Study information

• Verified date: April 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Post Thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Syndrome
• Thrombosis
• Venous Thrombosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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