Clinical trial NCT03039517: Post Thrombotic Syndrome Prevention Study
Official title: Post Thrombotic Syndrome Prevention Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post Thrombotic Syndrome
Deep Vein Thrombosis
Keywords: Adaptive Compression Therapy Delivery System
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Villalta Score
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Thomas Maldonado, MD
role: PRINCIPAL_INVESTIGATOR
References: