Acute DVT of Lower ExtremityNCT03465735
Vascular Boot Warming Program After Acute Deep Vein Thrombosis (DVT) ± Pulmonary Embolism (PE)
A study testing Vascular Boot in people with Acute DVT of Lower Extremity, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute DVT of Lower Extremity
- What is being tested?
- Vascular Boot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2017to 3 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Acute DVT of Lower Extremity
- Being tested
- Vascular Boot, Standard of Care
- Keywords
- Deep, Pulmonary, Venous, Vascular, Post, Vein, Thrombosis, Embolism, Thromboembolism, Thrombotic, Syndrome
- Medical subject headings
- Thrombosis, Embolism, Thromboembolism, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular BootCombination product
Also called Rooke 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 CareDrug
Also called Heparin, Enoxaparin (Lovenox), Dalteparin (Fragmin), Warfarin (Coumadin, Jantoven)
Anticoagulant therapy will be decided by physician and patient.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | 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. Receives: Drug: Standard of Care |
| Vascular Boot Group | Other | 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 Receives: Combination Product: Vascular Boot; Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Affected Leg Pain
Affected leg pain measured on a 0-10 scale. 0 indicating No pain and 10 indicating Worst Possible Pain.
Measured: baseline, 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start13 Jan 2017
- Primary completion29 Aug 2019
- Study completion3 Jan 2020
Why it stopped: Due to lack of recruitment of eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Acute DVT of Lower ExtremityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waldemar E. Wysokinski, Mayo Clinic
- Investigators
- Waldemar E Wysokinski, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465735
- Sponsor's protocol ID
- 16-008129
- Status last verified
- May 2020
- First submitted
- 8 Mar 2018
- Last updated
- 12 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Heit JA. The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):370-2. doi: 10.1161/ATVBAHA.108.162545. No abstract available.
PubMed 18296591Centers for Disease Control and Prevention (CDC). Venous thromboembolism in adult hospitalizations - United States, 2007-2009. MMWR Morb Mortal Wkly Rep. 2012 Jun 8;61(22):401-4.
PubMed 22672974Heit 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.
Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, Weitz JI; American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014 Oct 28;130(18):1636-61. doi: 10.1161/CIR.0000000000000130. Epub 2014 Sep 22. No abstract available.
PubMed 25246013Kahn SR, Shapiro S, Wells PS, Rodger MA, Kovacs MJ, Anderson DR, Tagalakis V, Houweling AH, Ducruet T, Holcroft C, Johri M, Solymoss S, Miron MJ, Yeo E, Smith R, Schulman S, Kassis J, Kearon C, Chagnon I, Wong T, Demers C, Hanmiah R, Kaatz S, Selby R, Rathbun S, Desmarais S, Opatrny L, Ortel TL, Ginsberg JS; SOX trial investigators. Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet. 2014 Mar 8;383(9920):880-8. doi: 10.1016/S0140-6736(13)61902-9. Epub 2013 Dec 6.
PubMed 24315521O'shaughnessy AM, Fitzgerald DE. The patterns and distribution of residual abnormalities between the individual proximal venous segments after an acute deep vein thrombosis. J Vasc Surg. 2001 Feb;33(2):379-84. doi: 10.1067/mva.2001.111983.
PubMed 11174793Killewich LA, Macko RF, Cox K, Franklin DR, Benjamin ME, Lilly MP, Flinn WR. Regression of proximal deep venous thrombosis is associated with fibrinolytic enhancement. J Vasc Surg. 1997 Nov;26(5):861-8. doi: 10.1016/s0741-5214(97)70101-0.
PubMed 9372826Killewich LA, Bedford GR, Beach KW, Strandness DE Jr. Spontaneous lysis of deep venous thrombi: rate and outcome. J Vasc Surg. 1989 Jan;9(1):89-97.
PubMed 2911146van Ramshorst B, van Bemmelen PS, Hoeneveld H, Faber JA, Eikelboom BC. Thrombus regression in deep venous thrombosis. Quantification of spontaneous thrombolysis with duplex scanning. Circulation. 1992 Aug;86(2):414-9. doi: 10.1161/01.cir.86.2.414.
PubMed 1638710Caprini JA, Arcelus JI, Hoffman KN, Size G, Laubach M, Traverso CI, Coats R, Finke N, Reyna JJ. Venous duplex imaging follow-up of acute symptomatic deep vein thrombosis of the leg. J Vasc Surg. 1995 Mar;21(3):472-6. doi: 10.1016/s0741-5214(95)70289-x.
PubMed 7877229Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galie N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.
PubMed 24716681Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Jones NJ, Gurley JC, Bhatheja R, Kennedy RJ, Goswami N, Natarajan K, Rundback J, Sadiq IR, Liu SK, Bhalla N, Raja ML, Weinstock BS, Cynamon J, Elmasri FF, Garcia MJ, Kumar M, Ayerdi J, Soukas P, Kuo W, Liu PY, Goldhaber SZ; SEATTLE II Investigators. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-1392. doi: 10.1016/j.jcin.2015.04.020.
PubMed 26315743Ogawa T, Hoshino S, Midorikawa H, Sato K. Intermittent pneumatic compression of the foot and calf improves the outcome of catheter-directed thrombolysis using low-dose urokinase in patients with acute proximal venous thrombosis of the leg. J Vasc Surg. 2005 Nov;42(5):940-4. doi: 10.1016/j.jvs.2005.07.041.
PubMed 16275451Murphy TP, Cutlip DE, Regensteiner JG, Mohler ER, Cohen DJ, Reynolds MR, Massaro JM, Lewis BA, Cerezo J, Oldenburg NC, Thum CC, Goldberg S, Jaff MR, Steffes MW, Comerota AJ, Ehrman J, Treat-Jacobson D, Walsh ME, Collins T, Badenhop DT, Bronas U, Hirsch AT; CLEVER Study Investigators. Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study. Circulation. 2012 Jan 3;125(1):130-9. doi: 10.1161/CIRCULATIONAHA.111.075770. Epub 2011 Nov 16.
PubMed 22090168
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03465735
- Acronym / sponsor ID
- 16-008129
- Conditions
- Acute DVT of Lower Extremity
- Keywords
- Deep, Pulmonary, Venous, Vascular, Post, Vein, Thrombosis, Embolism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of recruitment of eligible participants
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Drug: Standard of CareUltrasound 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. |
| Vascular Boot Group | Other | Combination Product: Vascular Boot, Drug: Standard of CareFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular BootAlso: Rooke BootThe 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. | Combination product | Vascular Boot Group |
| Standard of CareAlso: Heparin, Enoxaparin (Lovenox), Dalteparin (Fragmin), Warfarin (Coumadin, Jantoven)Anticoagulant therapy will be decided by physician and patient. | Drug | Standard of Care, Vascular Boot Group |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18296591Heit JA. The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):370-2. doi: 10.1161/ATVBAHA.108.162545. No abstract available.
- Background: PubMed 22672974Centers for Disease Control and Prevention (CDC). Venous thromboembolism in adult hospitalizations - United States, 2007-2009. MMWR Morb Mortal Wkly Rep. 2012 Jun 8;61(22):401-4.
- BackgroundHeit 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.
- BackgroundHeit 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.
- Background: PubMed 25246013Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, Weitz JI; American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014 Oct 28;130(18):1636-61. doi: 10.1161/CIR.0000000000000130. Epub 2014 Sep 22. No abstract available.
- Background: PubMed 24315521Kahn SR, Shapiro S, Wells PS, Rodger MA, Kovacs MJ, Anderson DR, Tagalakis V, Houweling AH, Ducruet T, Holcroft C, Johri M, Solymoss S, Miron MJ, Yeo E, Smith R, Schulman S, Kassis J, Kearon C, Chagnon I, Wong T, Demers C, Hanmiah R, Kaatz S, Selby R, Rathbun S, Desmarais S, Opatrny L, Ortel TL, Ginsberg JS; SOX trial investigators. Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet. 2014 Mar 8;383(9920):880-8. doi: 10.1016/S0140-6736(13)61902-9. Epub 2013 Dec 6.
- Background: PubMed 11174793O'shaughnessy AM, Fitzgerald DE. The patterns and distribution of residual abnormalities between the individual proximal venous segments after an acute deep vein thrombosis. J Vasc Surg. 2001 Feb;33(2):379-84. doi: 10.1067/mva.2001.111983.
- Background: PubMed 9372826Killewich LA, Macko RF, Cox K, Franklin DR, Benjamin ME, Lilly MP, Flinn WR. Regression of proximal deep venous thrombosis is associated with fibrinolytic enhancement. J Vasc Surg. 1997 Nov;26(5):861-8. doi: 10.1016/s0741-5214(97)70101-0.
- Background: PubMed 2911146Killewich LA, Bedford GR, Beach KW, Strandness DE Jr. Spontaneous lysis of deep venous thrombi: rate and outcome. J Vasc Surg. 1989 Jan;9(1):89-97.
- Background: PubMed 1638710van Ramshorst B, van Bemmelen PS, Hoeneveld H, Faber JA, Eikelboom BC. Thrombus regression in deep venous thrombosis. Quantification of spontaneous thrombolysis with duplex scanning. Circulation. 1992 Aug;86(2):414-9. doi: 10.1161/01.cir.86.2.414.
- Background: PubMed 7877229Caprini JA, Arcelus JI, Hoffman KN, Size G, Laubach M, Traverso CI, Coats R, Finke N, Reyna JJ. Venous duplex imaging follow-up of acute symptomatic deep vein thrombosis of the leg. J Vasc Surg. 1995 Mar;21(3):472-6. doi: 10.1016/s0741-5214(95)70289-x.
- Background: PubMed 24716681Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galie N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Acute DVT of Lower Extremity
RecruitingObservational study
Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
Venous Embolism of Lower Extremities (Diagnosis), Arterial Embolism and Thrombosis
Recruiting
DVT Burden and the Risk of Post-thrombotic Syndrome
Postthrombotic Syndrome
Not yet recruiting
Acute or Subacute Iliofemoral Vein Thrombosis: Aspiration for Flow Restoration Versus Standard Anticoagulation
Deep Vein Thrombosis of Lower Limb, Postthrombotic Syndrome
Not yet recruitingPhase 3
Design and Rationale of the COLT Study
Venous Thrombosis Deep (Limbs), Post-thrombotic Syndrome
Active, not recruitingObservational study
Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System
Acute Deep Venous Thrombosis of Ileofemoral Vein
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waldemar E Wysokinski, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular Boot in people with Acute DVT of Lower Extremity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Affected Leg Pain (time frame: baseline, 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465735, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.