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Postphlebitic Syndrome clinical trials

View clinical trials related to Postphlebitic Syndrome.

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NCT ID: NCT03543007 Not yet recruiting - Venous Leg Ulcer Clinical Trials

Evaluating the Safety and Efficacy of GrafixPLâ„¢PRIME for the Treatment of Chronic Venous Leg Ulcers

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Approximately 200 patients (100 in each treatment group) nationally with chronic venous leg ulcers will be randomized to GrafixPLâ„¢PRIME plus standard compression therapy or standard compression therapy alone for up to 12 weeks in order to compare the clinical outcomes between the two groups. Specifically, at this Georgetown site, approximately 30 subjects will be recruited.

NCT ID: NCT03413618 Completed - Clinical trials for Deep Vein Thrombosis

Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis

RIDILOTT-DVT
Start date: December 20, 2017
Phase: Phase 4
Study type: Interventional

The randomized clinical study aimed to assess the efficacy and safety of standard anticoagulation with rivaroxaban in combination with diosmin compared to the isolated use of standard rivaroxaban for prolonged therapy of acute femoro-popliteal deep vein thrombosis reflected the speed of deep vein recanalization and incidence of post-thrombotic syndrome.

NCT ID: NCT03368313 Recruiting - Clinical trials for Deep Vein Thrombosis

Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

The objective of the study is to conduct a Bayesian randomized trial comparing non-elastic compression garments applied with high pressure (Circaid group) with no compression (control group) in reducing signs and symptoms in the acute stage of DVT and subsequent postthrombotic syndrome. With a hypothesis that the Circaid group will present a quicker and more marked reduction of pain and leg swelling in the acute stage of DVT, as well as a 20% decrease in the frequency of postthrombotic syndrome within six months from the time of diagnosis of the acute deep vein thrombosis episode.

NCT ID: NCT03329430 Completed - Foot Clinical Trials

Custom Foot Orthoses & Venous Status

Start date: November 5, 2017
Phase: N/A
Study type: Interventional

The purpose of the research is to compare the influence of customized foot orthoses use on the venous status among healthy female and male subjects. This is a quasi-experimental study which included 20 healthy subjects. Sociodemographic and medical record data are registered. Furthermore,venous function is evaluated by plethysmography, first, without orthoses and, after 20 days, with orthoses.

NCT ID: NCT03250247 Recruiting - Clinical trials for Deep Vein Thrombosis

Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)

C-TRACT
Start date: July 2, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the use of image-guided, endovascular therapy (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease severity and improve quality of life in patients with established disabling iliac-obstructive post thrombotic syndrome (DIO-PTS).

NCT ID: NCT03195777 Active, not recruiting - Clinical trials for Deep Venous Thrombosis

Novel PET/CT and Treatment Strategies to Reduce PTS Following DVT

Start date: December 20, 2017
Phase: N/A
Study type: Interventional

The goal of this study is to develop strategies that will improve outcomes for patients with deep vein thrombosis (DVT), using in vivo FDG-PET inflammation imaging to better predict the development of the post-thrombotic syndrome (PTS). New approaches are needed to improve the outcomes of patients with DVT, a disease that affects up to 600,000 patients per year in the US alone. DVT acutely places patients at risk of death from pulmonary embolism and causes 50,000 deaths annually in the US. Moreover, up to 30-50% of patients will develop PTS, an illness characterized by inflammation-driven fibrotic vein wall injury, and persistent thrombus obstruction. PTS occurs despite anticoagulant therapy, and produces chronic disability from leg pain, heaviness, edema, skin pigmentation, and ulcers; some patients may even require amputation. PTS impairs quality of life to the same extent as chronic obstructive pulmonary disease or diabetes. Therefore new diagnostic insights into PTS are urgently needed. There are several major challenges to improve outcomes in PTS: A) Limited in vivo knowledge regarding inflammation and the development of PTS; B) L Lack of predictive approaches to identify patients at high risk for PTS that will preferentially benefit from novel therapies. Recently, our laboratories have harnessed FDG-PET molecular imaging to illuminate DVT inflammation in vivo, and to provide a new strategy to diagnose recurrent DVT, a vexing clinical problem (Hara et al. Circulation 2014). We now propose to further develop FDG-PET to improve outcomes in DVT and PTS. The objective of this application is to develop FDG-PET as an inflammation imaging approach to assess DVT inflammation and predict risk of developing PTS in human subjects; Hypothesis 1A: Inflammatory activity in DVT (quantified acutely, using FDG-PET imaging within 0-7 days after DVT) will predict PTS incidence (primary) and severity (secondary) within a 24 month follow-up period. Hypothesis 1B: Inflammatory activity in DVTs (quantified sub-acutely, using FDG-PET imaging within 21-28 days after DVT), will predict PTS incidence and severity. Eighty patients with DVT will be imaged using FDG-PET/CT acutely (0-7 days of DVT diagnosis), and sub-acutely (21-28 days after diagnosis). Subjects will be evaluated repeatedly for up to 2 years to detect clinical evidence of PTS (Villalta score), ultrasound findings for structural venous injury, and soluble biomarkers of systemic inflammation. Subsequently, we will evaluate the relationship between FDG DVT activity and the development of PTS.

NCT ID: NCT03111758 Terminated - Clinical trials for Postthrombotic Syndrome

Flow Augmentation Study in Postthrombotic Patients

Start date: April 3, 2017
Phase: N/A
Study type: Interventional

Rationale: Stent therapy has been proven to be an effective form of therapy in the treatment of chronic iliofemoral and iliocaval post-thrombotic obstruction. During the first post-intervention day intermittent pneumatic compression stockings (IPCS) are necessary to augment venous flow. This will inherently prevent early stent occlusion. Our aim is to investigate whether the Geko device is effective as IPCS regarding augmentation of flow in post-thrombotic patients during the first day after stenting. Objective: The primary objective of this study is to identify whether the Geko system is effective in augmenting flow compared to IPCS in post-thrombotic limbs before after stenting. Study design: Interventional pilot study with randomized cross-sectional design. Study population: Patients with a post-thrombotic obstruction undergoing a percutaneous procedure (PTA, stenting). Intervention (if applicable): Treatment with intermittent pneumatic compression stockings (IPCS) and Geko-device. Main study parameters/endpoints: The main endpoint and parameter of this study is time-averaged maximum flow velocity (TAMFV), measured by duplex ultrasonography using its pulse wave Doppler function.

NCT ID: NCT03075761 Completed - Clinical trials for Deep Vein Thrombosis

Physical Activity in Children at Risk of Post-thrombotic Sequelae (PACT)

PACT
Start date: November 18, 2016
Phase: N/A
Study type: Interventional

'The PACT trial' is randomized pilot trial to demonstrate the feasibility and potential effectiveness of a personal "fitness tracker" to improve adherence to an activity regimen following an initial acute DVT in children.

NCT ID: NCT03054727 Completed - Clinical trials for Cardiovascular Diseases

Long Term Assessment of Post Thrombotic Syndrome : OPTIMEV Study ( SPOT )

SPOT
Start date: July 11, 2017
Phase:
Study type: Observational

Post-thrombotic syndrome (PTS) is a frequent and burdensome complication of deep-vein thrombosis (DVT). In the absence of curative treatment of established PTS, its management is based on the prevention of its occurrence thanks to anticoagulants and compression stockings. So far, predictors of disabling PTS are unknown precluding from optimally selecting patients for invasive (early thrombus removal) or innovative/expensive treatments. In addition, little is known on the incidence of PTS in the very long-term. Objectives: To assess, 12 years after a symptomatic venous thromboembolic (VTE) event, Primary objective: incidence and severity of PTS after a lower limb DVT. Main Secondary objectives: 1. Incidence and severity of PTS according to VTE initial presentation (isolated distal DVT, isolated proximal DVT, PE + DVT). 2. Incidence and risk factors of disabling PTS Methods: Very long-term follow-up (12 years) of patients recruited in the large, multicentre, prospective, observational OPTIMEV study for a suspicion of VTE confirmed or ruled out with objective tests (Clinical Trials NCT00670540). All patients with a DVT, an isolated PE and a random selection of controls (VTE - patients without any history of VTE after the 3 years of follow-up) will first benefit from a phone-PTS assessment. Those patients presenting at least a mild venous insufficiency and a selection of controls will undergo a clinical follow-up visit with clinical and Compleat Ultra Sound (CUS) assessment of PTS/venous insufficiency and an assessment of quality of life. Perspectives: Improving our knowledge of PTS' incidence and predictors and of the impact of usual treatment. Better selecting patients eligible for invasive/innovative/expensive preventative procedures.

NCT ID: NCT03050138 Completed - Clinical trials for Postthrombotic Syndrome

Prevalence of Post-Thrombotic Syndrome in Deep-Vein Thrombosis (DVT) Patients Treated With Dabigatran

DABI-PTS
Start date: April 2016
Phase:
Study type: Observational

The primary objective in this cross-sectional study is to assess the prevalence of post-thrombotic syndrome (PTS) in the two treatment arms of the RE-COVER studies (warfarin versus dabigatran). PTS will be assessed by the recently developed Patient Reported Villalta (PRV) Score. Secondary objectives: to assess in both treatment arms the 1. Prevalence of recurrent venous thromboembolism (VTE) after the discontinuation of study treatment. 2. Prevalence of PTS determined by the standard Villalta score. 3. Health related Quality of Life (HRQoL).