Post Thrombotic Syndrome Prevention Study

NCT03039517 | Withdrawn FDA Device

• 1 other identifier: 15-01178
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Thrombotic Syndrome; Deep Vein Thrombosis

Keywords

Adaptive Compression Therapy Delivery System

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ACTitouch - ACT-Adaptive Compression Therapy

EXPERIMENTAL

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

Standard Compression Stocking

EXPERIMENTAL

The control group will receive care using elastic compression stocking.

Device: Compression garments (stockings)

Interventions

ACTitouch DEVICE

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.

ACTitouch - ACT-Adaptive Compression Therapy

Compression garments (stockings) DEVICE

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.

Standard Compression Stocking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Postthrombotic Syndrome; Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Study Officials

• Thomas Maldonado, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 1, 2017
• Study Start: January 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

US (1)