Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT03465735
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.
Study:
NCT03465735
Study Brief:
Protocol Section:
NCT03465735