Post Thrombotic Syndrome Prevention Study

Not Applicable

Withdrawn

• Conditions: Post Thrombotic Syndrome; Deep Vein Thrombosis

• Registration Number: NCT03039517
• Lead Sponsor: NYU Langone Health

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 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 Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Villalta Score	2 Years	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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States