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

Sponsor
Mayo Clinic (Other)
Overall Status
Terminated
CT.gov ID
NCT03465735
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
35.6
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Vascular Boot
  • Drug: Standard of Care
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jan 13, 2017
Actual Primary Completion Date :
Aug 29, 2019
Actual Study Completion Date :
Jan 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Standard of Care

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
Anticoagulant therapy will be decided by physician and patient.
Other Names:
  • Heparin
  • Enoxaparin (Lovenox)
  • Dalteparin (Fragmin)
  • Warfarin (Coumadin, Jantoven)
  • Dabigatran (Pradaxa)
  • Rivaroxaban (Xarelto)
  • Apixaban (Eliquis)
  • Edoxaban (Savaysa)

    		•
    Other: Vascular Boot Group

    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
    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.
    Other Names:
  • Rooke Boot

    • Drug: Standard of Care
    Anticoagulant therapy will be decided by physician and patient.
    Other Names:
  • Heparin
  • Enoxaparin (Lovenox)
  • Dalteparin (Fragmin)
  • Warfarin (Coumadin, Jantoven)
  • Dabigatran (Pradaxa)
  • Rivaroxaban (Xarelto)
  • Apixaban (Eliquis)
  • Edoxaban (Savaysa)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Affected Leg Pain [baseline, 10 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Waldemar E Wysokinski, MD, PhD, Mayo Clinic

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Waldemar E. Wysokinski, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03465735
    Other Study ID Numbers:
    • 16-008129
    First Posted:
    Mar 14, 2018
    Last Update Posted:
    Aug 12, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Waldemar E. Wysokinski, Principal Investigator, Mayo Clinic
    Deep
    Pulmonary
    Venous
    Vascular
    Post
    Vein
    Thrombosis
    Embolism
    Thromboembolism
    Thrombotic
    Syndrome
    Additional relevant MeSH terms:
    Thrombosis
    Thromboembolism
    Heparin
    Enoxaparin
    Dalteparin
    Warfarin
    Rivaroxaban
    Dabigatran
    Apixaban
    Edoxaban

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Standard of Care Vascular Boot Group
    Arm/Group 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. Standard of Care: Anticoagulant therapy will be decided by physician and patient. 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 Vascular Boot: 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. Standard of Care: Anticoagulant therapy will be decided by physician and patient.
    Period Title: Overall Study
    STARTED 8 7
    COMPLETED 7 5
    NOT COMPLETED 1 2

    Baseline Characteristics

    Arm/Group Title Standard of Care Vascular Boot Group Total
    Arm/Group 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. Standard of Care: Anticoagulant therapy will be decided by physician and patient. 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 Vascular Boot: 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. Standard of Care: Anticoagulant therapy will be decided by physician and patient. Total of all reporting groups
    Overall Participants 8 7 15
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    55.7
    (17.5)
    66.4
    (13.6)
    61.1
    (16.6)
    Sex: Female, Male (Count of Participants)
    Female
    4
    50%
    6
    85.7%
    10
    66.7%
    Male
    4
    50%
    1
    14.3%
    5
    33.3%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    8
    100%
    7
    100%
    15
    100%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Study terminated due to lack of recruitment of eligible participants. Data was not analyzed due to lack of recruitment. Data not analyzed and no longer available to be analyzed.
    Arm/Group Title Standard of Care Vascular Boot Group
    Arm/Group 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. Standard of Care: Anticoagulant therapy will be decided by physician and patient. 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 Vascular Boot: 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. Standard of Care: Anticoagulant therapy will be decided by physician and patient.
    Measure Participants 0 0

    Adverse Events

    Time Frame Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.
    Adverse Event Reporting Description
    Arm/Group Title Standard of Care Vascular Boot Group
    Arm/Group 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. Standard of Care: Anticoagulant therapy will be decided by physician and patient. 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 Vascular Boot: 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. Standard of Care: Anticoagulant therapy will be decided by physician and patient.
    All Cause Mortality
    Standard of Care Vascular Boot Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/8 (0%) 0/7 (0%)
    Serious Adverse Events
    Standard of Care Vascular Boot Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/8 (0%) 0/7 (0%)
    Other (Not Including Serious) Adverse Events
    Standard of Care Vascular Boot Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/8 (87.5%) 0/7 (0%)
    Cardiac disorders
    Occlusive thrombi 1/8 (12.5%) 1 0/7 (0%) 0
    Chest Pain 1/8 (12.5%) 1 0/7 (0%) 0
    Injury, poisoning and procedural complications
    Chemical Exposure 1/8 (12.5%) 1 0/7 (0%) 0
    Musculoskeletal and connective tissue disorders
    Thoracic Back Pain 1/8 (12.5%) 1 0/7 (0%) 0
    Renal and urinary disorders
    Dysuria 1/8 (12.5%) 1 0/7 (0%) 0
    Hematuria 1/8 (12.5%) 1 0/7 (0%) 0
    Left adnexal cyst 1/8 (12.5%) 1 0/7 (0%) 0

    Limitations/Caveats

    Early termination due to lack of recruitment of eligible participants.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Waldemar E. Wysokinski, M.D., Ph.D.
    Organization Mayo Clinic
    Phone 507-266-6717
    Email Wysokinski.Waldemar@mayo.edu
    Responsible Party:
    Waldemar E. Wysokinski, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03465735
    Other Study ID Numbers:
    • 16-008129
    First Posted:
    Mar 14, 2018
    Last Update Posted:
    Aug 12, 2020
    Last Verified:
    May 1, 2020