An interventional study of Vascular Boot and Standard of Care in Acute DVT of Lower Extremity, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
Among 303 studies in Thrombosis with a site in United States — 43 open to participants now, 49 under way, 5 of them phase 3. Thrombosis · United States.
Among the 303 studies in Thrombosis with a site in United States, this one is the 154th largest by enrollment of the 188 interventional ones that give a count, is one of 19 that started in 2017, is one of 50 with no phase, and was the 201st registered.
955 studies on the registry are indexed under Thrombosis; 171 are open to participants now.
Browse Thrombosis studies →43 of the 303 studies in Thrombosis with a site in United States are open now. Recruiting first, the newest first:
Columbia University · Sites in United States
Regeneron Pharmaceuticals · Sites in United States, Canada, Japan
OHSU Knight Cancer Institute · Sites in United States
Regeneron Pharmaceuticals · Sites in United States, United Kingdom
Brigham and Women's Hospital · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 126 Thrombosis studies recruiting now, 79 (63%) set no upper age limit and 16 (13%) stop at 75 or younger; 20 take children under 18; 20 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
303 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 34 · Phase 2 45 · Phase 3 38 · Phase 4 30
First in 1996; this study’s year is marked. 19 started in 2017.
This study's enrollment of 15 is below the median of 83 across 530 interventional studies indexed under Thrombosis.
Median enrollment 67 across the 188 interventional studies, 154 across the 112 observational. Of the 228 that completed or were terminated, 94 (41%) have results posted.
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110 of 303 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 2 studies filed under Thrombosis — fewer than ten, so there is no comparison to draw.
15 of the studies in Thrombosis with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07560306Phase 3Brigham and Women's Hospital[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy | 2027-03-30 |
| NCT05967741University of California, DavisThe Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation | 2026-12 |
| NCT04299828Boston Children's HospitalEvaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery | 2026-12 |
| NCT06434207Boston Children's HospitalExtracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis | 2026-12-01 |
| NCT04790240All Natural Medicine Clinic, LLCMedical Herbs Inhibit Inflammation Directing T Cells to Kill the COVID-19 Virus (COVID) | 2026-12-30 |
Among the 303 studies in Thrombosis with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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 · Drug: Standard of Care
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.
Also known as: Rooke Boot
Anticoagulant therapy will be decided by physician and patient.
Also known as: Heparin, Enoxaparin (Lovenox), Dalteparin (Fragmin), Warfarin (Coumadin, Jantoven), Dabigatran (Pradaxa), Rivaroxaban (Xarelto), Apixaban (Eliquis), Edoxaban (Savaysa)
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
| Milestone | Standard of Care | Vascular Boot Group |
|---|---|---|
| Started | 8 | 7 |
| Completed | 7 | 5 |
| Not completed | 1 | 2 |
Affected leg pain measured on a 0-10 scale. 0 indicating No pain and 10 indicating Worst Possible Pain.
No measurements were reported for this outcome.
Collected over Adverse Events were collect on each subject from baseline to end of anti coagulation program for approximately a total of three months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 0/8 (0%) | 0/8 (0%) | 7/8 (87.5%) |
| Vascular Boot Group | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Event | Standard of Care | Vascular Boot Group |
|---|---|---|
| Occlusive thrombiCardiac disorders | 1/8 | 0/7 |
| Thoracic Back PainMusculoskeletal and connective tissue disorders | 1/8 | 0/7 |
| Chest PainCardiac disorders | 1/8 | 0/7 |
| Chemical ExposureInjury, poisoning and procedural complications | 1/8 | 0/7 |
| DysuriaRenal and urinary disorders | 1/8 | 0/7 |
| HematuriaRenal and urinary disorders | 1/8 | 0/7 |
| Left adnexal cystRenal and urinary disorders | 1/8 | 0/7 |
| Age, Continuous(years) | Standard of Care | Vascular Boot Group | Total |
|---|---|---|---|
| Mean | 55.7 ± 17.5 | 66.4 ± 13.6 | 61.1 ± 16.6 |
| Sex: Female, Male(Participants) | Standard of Care | Vascular Boot Group | Total |
|---|---|---|---|
| Female | 4 | 6 | 10 |
| Male | 4 | 1 | 5 |
| Race and Ethnicity Not Collected(Participants) | Standard of Care | Vascular Boot Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Standard of Care | Vascular Boot Group | Total |
|---|---|---|---|
| United States | 8 | 7 | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2017 to primary completion in Aug 2019, 31 months.
Results were first posted in Aug 2020, 11 months after primary completion.
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This study is terminated, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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