Post Thrombotic Syndrome Prevention Study
Withdrawn before enrolling · Not applicable
Conditions studied: Post Thrombotic Syndrome, Deep Vein Thrombosis
In brief
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.
Key facts
- Study ID
- NCT03039517
- Run by
- NYU Langone Health
- People needed
- 0
- Starts
- 2017-01-01
- Expected to finish
- 2018-02-01
- Last updated by the study team
- 2019-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- New York University School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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