Acute DVT of Lower Extremity
Conditions
Keywords
Deep, Pulmonary, Venous, Vascular, Post, Vein, Thrombosis, Embolism, Thromboembolism, Thrombotic, Syndrome
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.
Interventions
COMBINATION_PRODUCTVascular 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.
DRUGStandard of Care
Anticoagulant therapy will be decided by physician and patient.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Standard of Care: Anticoagulant therapy will be decided by physician and patient. | 8 |
| 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
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. | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | Vascular Boot Group | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 13.6 | 61.1 years STANDARD_DEVIATION 16.6 | 55.7 years STANDARD_DEVIATION 17.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 7 participants | 15 participants | 8 participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 7 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
Change in Affected Leg Pain
Affected leg pain measured on a 0-10 scale. 0 indicating No pain and 10 indicating Worst Possible Pain.
Time frame: baseline, 10 days
Population: 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.