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Post Thrombotic Syndrome Prevention Study

Primary Purpose

Post Thrombotic Syndrome, Deep Vein Thrombosis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACTitouch
Compression garments (stockings)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Thrombotic Syndrome focused on measuring Adaptive Compression Therapy Delivery System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ACTitouch - ACT-Adaptive Compression Therapy

Standard Compression Stocking

Arm Description

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.

The control group will receive care using elastic compression stocking.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 30, 2017
Last Updated
April 18, 2019
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03039517
Brief Title
Post Thrombotic Syndrome Prevention Study
Official Title
Post Thrombotic Syndrome Prevention Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
staffing change and lack of resources to conduct the study.
Study Start Date
January 2017 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Thrombotic Syndrome, Deep Vein Thrombosis
Keywords
Adaptive Compression Therapy Delivery System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
subjects who meet the study entrance criteria 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 DVT has iliac or non-iliac involvement.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACTitouch - ACT-Adaptive Compression Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Compression Stocking
Arm Type
Experimental
Arm Description
The control group will receive care using elastic compression stocking.
Intervention Type
Device
Intervention Name(s)
ACTitouch
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Compression garments (stockings)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Villalta Score
Description
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
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Maldonado, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Post Thrombotic Syndrome Prevention Study

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