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

Primary Purpose

Acute DVT of Lower Extremity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vascular Boot
Standard of Care
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute DVT of Lower Extremity focused on measuring Deep, Pulmonary, Venous, Vascular, Post, Vein, Thrombosis, Embolism, Thromboembolism, Thrombotic, Syndrome

Eligibility Criteria

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

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Standard of Care

Vascular Boot Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in Affected Leg Pain
Affected leg pain measured on a 0-10 scale. 0 indicating No pain and 10 indicating Worst Possible Pain.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2018
Last Updated
July 30, 2020
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03465735
Brief Title
Vascular Boot Warming Program After Acute Deep Vein Thrombosis (DVT) ± Pulmonary Embolism (PE)
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to lack of recruitment of eligible participants
Study Start Date
January 13, 2017 (Actual)
Primary Completion Date
August 29, 2019 (Actual)
Study Completion Date
January 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute DVT of Lower Extremity
Keywords
Deep, Pulmonary, Venous, Vascular, Post, Vein, Thrombosis, Embolism, Thromboembolism, Thrombotic, Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Other
Arm Description
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.
Arm Title
Vascular Boot Group
Arm Type
Other
Arm Description
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
Intervention Type
Combination Product
Intervention Name(s)
Vascular Boot
Other Intervention Name(s)
Rooke Boot
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Heparin, Enoxaparin (Lovenox), Dalteparin (Fragmin), Warfarin (Coumadin, Jantoven), Dabigatran (Pradaxa), Rivaroxaban (Xarelto), Apixaban (Eliquis), Edoxaban (Savaysa)
Intervention Description
Anticoagulant therapy will be decided by physician and patient.
Primary Outcome Measure Information:
Title
Change in Affected Leg Pain
Description
Affected leg pain measured on a 0-10 scale. 0 indicating No pain and 10 indicating Worst Possible Pain.
Time Frame
baseline, 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waldemar E Wysokinski, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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

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