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

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ClinicalTrials.gov Identifier: NCT03465735
Recruitment Status : Enrolling by invitation
First Posted : March 14, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Waldemar E. Wysokinski, Mayo Clinic

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
Acute DVT of Lower Extremity Combination Product: Vascular Boot Drug: Standard of Care Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 VTE and Prevention of Post Thrombotic Syndrome: A Pilot Study.
Actual Study Start Date : January 13, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)
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 Name: 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)



Primary Outcome Measures :
  1. Change in affected leg pain [ Time Frame: baseline, 10 days ]
    Affected leg pain measured on a 0-10 scale. 0 indicating No pain and 10 indicating Worst Possible Pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465735


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Waldemar E Wysokinski, MD, PhD Mayo Clinic

Publications:
Heit JA, Crusan DJ, Ashrani AA, Petterson TM, Bailey KR. Venous thromboembolism attack rates among recently hospitalized vs. community residents: a population-based cohort study. JAMA. 2015 in submission.
Heit JA, Ashrani AA, Crusan DJ, Petterson TM, Bailey KR. Trends in venous thromboembolism incidence, 1981-2010: a population-based cohort study. JAMA. 2015, in submission.

Responsible Party: Waldemar E. Wysokinski, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03465735     History of Changes
Other Study ID Numbers: 16-008129
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Waldemar E. Wysokinski, Mayo Clinic:
Deep
Pulmonary
Venous
Vascular
Post
Vein
Thrombosis
Embolism
Thromboembolism
Thrombotic
Syndrome

Additional relevant MeSH terms:
Postthrombotic Syndrome
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency