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

NCT03465735 | Terminated Results FDA Device

• 1 other identifier: 16-008129
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute DVT of Lower Extremity

Keywords

Deep; Pulmonary; Venous; Vascular; Post; Vein; Thrombosis; Embolism; Thromboembolism; Thrombotic; Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Affected Leg Pain

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

  baseline, 10 days

Study Arms (2)

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.

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

Combination Product: Vascular Boot; Drug: Standard of Care

Interventions

Vascular Boot COMBINATION_PRODUCT

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

Vascular Boot Group

Standard of Care DRUG

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)

Standard of Care; Vascular Boot Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (19)

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• Centers 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.

  PMID: 22672974 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

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  PMID: 11174793 BACKGROUND

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  PMID: 9372826 BACKGROUND

• Killewich 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.

  PMID: 2911146 BACKGROUND

• van 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.

  PMID: 1638710 BACKGROUND

• Caprini 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.

  PMID: 7877229 BACKGROUND

• Meyer 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.

  PMID: 24716681 BACKGROUND

• Piazza 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.

  PMID: 26315743 BACKGROUND

• Ogawa 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.

  PMID: 16275451 BACKGROUND

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• Recek C. Calf pump activity influencing venous hemodynamics in the lower extremity. Int J Angiol. 2013 Mar;22(1):23-30. doi: 10.1055/s-0033-1334092.

  PMID: 24436580 BACKGROUND

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  PMID: 8615726 BACKGROUND

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  PMID: 15809562 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Thrombosis; Embolism; Thromboembolism; Syndrome

Interventions

Standard of Care; Heparin; Enoxaparin; Dalteparin; Warfarin; Vitamin B 6; Dabigatran; Rivaroxaban; apixaban; edoxaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Glycosaminoglycans; Polysaccharides; Carbohydrates; Heparin, Low-Molecular-Weight; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Picolines; Pyridines; Benzimidazoles; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Limitations and Caveats

Early termination due to lack of recruitment of eligible participants.

Results Point of Contact

• Title: Waldemar E. Wysokinski, M.D., Ph.D.
• Organization: Mayo Clinic

Wysokinski.Waldemar@mayo.edu

507-266-6717

Study Officials

• Waldemar E Wysokinski, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 14, 2018
• Study Start: January 13, 2017
• Primary Completion: August 29, 2019
• Study Completion: January 3, 2020
• Last Updated: August 12, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)