Vascular Boot Warming Program After Acute Deep Vein Thrombosis (DVT) ± Pulmonary Embolism (PE)

Study Overview
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Brief Summary
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The Researchers are studying whether a vascular boot warming program plus standard of care anticoagulation can be a safe and effective method to resolve Deep Vein Thrombosis (DVT) ±Pulmonary Embolism (PE) earlier and prevent development of post-thrombotic syndrome (PTS). Additionally, to learn whether a more detailed imaging of the affected lower extremities will provide a more accurate and reliable method to guide treatment for this condition.

Detailed Description
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Participants with diagnosis of acute lower extremity DVT (proximal and distal) and/or pulmonary embolism will be identified and approached for participation, when they are seen in the Thrombophilia Clinic or Mayo Hospital for management of the acute VTE. If they match the preset inclusion and exclusion criteria, they would then be consented during this visit and scheduled for baseline studies at a later date. Baseline tests include Venous plethysmorgraphy, Lower Extremity Ultrasound, and Medical history, will be conducted and if eligible, participant will then be randomized to vascular boot plus standard anti coagulation program or standard anti coagulation using a randomization program. Participants will be randomized into two groups and followed for 3 months. Standard of Care (SOC) Group (no vascular boot utilized): Patients will receive standard anticoagulation (determined at discretion of the treating provider), baseline studies, and follow up at the end of treatment (3months). Vascular Boot (VB) Group (includes vascular boot in addition to SOC): Patients will receive standard anticoagulation (determined at discretion of the treating provider), baseline studies and standardized vascular boot warming. All patients randomized to this group will wear the vascular boot for a minimum of 30 minutes per day for the first 10 days of participation. Patients in this group may initially be enrolled at either the thrombophilia clinic or the hospital.

Official Title
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Efficacy and Safety of Vascular Boot Warming Program After Acute DVT±PE for Earlier Resolution of Venous Thromboembolism (VTE) and Prevention of Post Thrombotic Syndrome: A Pilot Study.

Conditions
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Acute DVT of Lower Extremity

Intervention / Treatment
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* Combination Product: Vascular Boot
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to tolerate wearing a vascular boot, if randomized to this group. Diagnosis of acute DVT±PE (within 24 - 48 hours) and received approximately 24 hours of anticoagulation prior to starting the study. Exclusion Criteria: Unable to tolerate wearing a vascular boot Unable to comply with keeping log of activity/ of wearing a vascular boot. Weight > 300 pounds. (weight limit for the venous plethysmography chair) Previous history of DVT or PE. On anticoagulation for another purpose (example stroke prevention with atrial fibrillation). Patients who do not accept to participate in research studies. Pregnant women will not be allowed to participate Patients less than 18 yrs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care<br>Ultrasound of the leg with DVT and leg circumference measurement at 3 days, 10 days, and 3 months. Ultrasound data will include data on thrombus resolution, such as size and recanalization present. | Drug: Standard of Care<br>* Anticoagulant therapy will be decided by physician and patient.<br>* Other names: Edoxaban (Savaysa);|
| Other: Vascular Boot Group<br>For each vascular boot session, the following data will be recorded: Wearing the vascular boot during first 10 days of study for minimum of 30 minutes per day | Combination Product: Vascular Boot<br>* The Vascular Boot is one size fits all, insulated fleece padding, and cell foam to enhance and maintain lower limb warmth while maintaining no pressure points on the lower extremity.<br>* Other names: Rooke Boot;Drug: Standard of Care<br>* Anticoagulant therapy will be decided by physician and patient.<br>* Other names: Edoxaban (Savaysa);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Affected Leg Pain | Affected leg pain measured on a 0-10 scale. 0 indicating No pain and 10 indicating Worst Possible Pain. | baseline, 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep, Pulmonary, Venous, Vascular, Post, Vein, Thrombosis, Embolism, Thromboembolism, Thrombotic, Syndrome