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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04696354
Registration number
NCT04696354
Ethics application status
Date submitted
14/12/2020
Date registered
6/01/2021
Date last updated
25/01/2023
Titles & IDs
Public title
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
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Scientific title
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers
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Secondary ID [1]
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200202
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Secondary ID [2]
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IGT_IGD_VLU_2020_10876
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Universal Trial Number (UTN)
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Trial acronym
IGuideU
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Ulcer of Leg
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Skin
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Other skin conditions
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Diagnosis / Prognosis - IVUS
Other interventions - Continued Compression Therapy/Stockings
Other: Interrogation Arm - patients will first be evaluated with MPV (limited to 3 views). The prescribed course of treatment based on the MPV results will be documented and patients will then be evaluated using IVUS. A treatment plan based on IVUS results will be compared with the MPV guided treatment plan and any differences will be documented. Any patients determined to still require venous stenting based on IVUS results will be stented accordingly using IVUS to guide stent placement.
Other: Deferred Interrogation Arm - Deferred Interrogation Guidelines for this study are as follows:
Mandate:
• Continued compression therapy/stockings as prescribed.
Allow:
Periodic leg elevation.
Sclerotherapy under ulcer bed.
Recommend mechanical debridement as needed.
Wound biopsy if evidence of infection.
Systemic antibiotics if patient is diagnosed with an infection, avoid prophylactic prescription.
Pain management medication (Pentoxifylline/Trental) allowed but not recommended
Topical antimicrobial as needed.
Prohibit:
Negative pressure systems.
Artificial and/or autologous skin grafting within first 3 months after randomization and within the first 3 months for subjects that crossover from deferred interrogation to the interrogation arm.
Diagnosis / Prognosis: IVUS
Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan.
Other interventions: Continued Compression Therapy/Stockings
Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed.
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Intervention code [1]
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Diagnosis / Prognosis
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of detection and difference in complete ulcer healing between the interrogation group and the deferred interrogation group
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Assessment method [1]
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Rate of detection and difference in complete ulcer healing between the interrogation group and the deferred interrogation group at 3 months. Complete ulcer healing is defined by 100% epithelialization of the venous ulcer. Healing will not be assumed for any area of the wound where a scab is present.
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Timepoint [1]
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3 Months
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Primary outcome [2]
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Composite of the difference in deep venous obstruction (DVO) detection and the subsequent changes in treatment plan informed by IVUS compared to MPV.
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Assessment method [2]
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Composite of the difference in DVO detection and the subsequent changes in treatment plan informed by IVUS compared to multiplanar venography (MPV). DVO is defined as =50% diameter reduction in the deep venous system as assessed by MPV or =50% reduction in cross-section area of the deep venous system assessed by IVUS. Changes in treatment plan will be assessed by use of a patient diary and follow up patient visits up to 24 months.
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Timepoint [2]
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24 months
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Secondary outcome [1]
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Rate of Ulcer healing measured
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Assessment method [1]
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Rate of ulcer healing measured between groups at 3,6,12,18, and 24 months
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Timepoint [1]
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3,6,12,18, and 24 months
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Secondary outcome [2]
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Rate of Ulcer healing for stented patients
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Assessment method [2]
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Rate of ulcer healing for stented post-thrombotic syndrome (PTS) and non-thrombotic iliac vein lesion (NIVL) patients at 3,6,12,18, and 24 months
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Timepoint [2]
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3,6,12,18, and 24 months
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Secondary outcome [3]
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Rate of recurring ulcers in both arms
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Assessment method [3]
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Rate recurring ulcers in both arms from 3 months out to follow-up visit 24 months provided each arm has at least 30 subjects. The choice of 30 is based on central limit theorem in order to have normally distributed data for descriptive summary statistics.
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Timepoint [3]
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3-24 months
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Secondary outcome [4]
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Rate of recurring ulcers between post-thrombotic syndrome and non-thrombotic iliac vein lesion patients
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Assessment method [4]
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Rate of recurring ulcers between PTS and NIVL sub-groups
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Timepoint [4]
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up to 24 months
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Secondary outcome [5]
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Change in Quality of Life scores using the EQ5D-5L as compared in both arms
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Assessment method [5]
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Change in QOL scores for both arms using the EQ5D-5L. The scale uses a scoring system of 0-100. Each response is assigned a number 1-5 and then added at the end to equal a number between 0-100. The higher the total, the better the score.
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Timepoint [5]
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up to 24 months
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Secondary outcome [6]
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Change in Quality of Life scores using the 36 Item Short Form question assessment as compared in both arms
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Assessment method [6]
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Change in QOL scores for both arms using the 36 Item Short Form question assessment. The responses are coded using a scoring key, then averaged to get a final score in each of the 8 categories utilized on the assessment. Items are scored ranging from 0-100. The higher the average, the better the score.
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Timepoint [6]
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up to 24 months
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Secondary outcome [7]
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Change in clinical score using the Venous Ulcer Assessment (VCSS)
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Assessment method [7]
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Change in clinical score will be assessed using the VCSS. The VCSS consists of 10 questions, each response is scored on a scale of 0-3. The total score ranges between 0-30 and is used to assess changes in disease severity over time. A lower score is a better outcome.
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Timepoint [7]
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up to 24 months
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Secondary outcome [8]
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Change in clinical classification using the Clinical Etiology and Anatomy Pathology classification system
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Assessment method [8]
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Change in clinical classification will be assessed using the Clinical Etiology and Anatomy Pathology (CEAP) scoring system. The system is designed to classify chronic venous disease. The clinical classification consists of 7 possibilities, ranging from 0-6, followed by sub categories to assign 1)symptoms, 2) etiologic classification, 3) anatomic classification, 4)pathophysiologic, and 5) anatomic segment classification. The lower the clinical classification score, the less severe the disease state.
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Timepoint [8]
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up to 24 months
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Secondary outcome [9]
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Rate of medical resource utilization between the interrogation arm and deferred interrogation arms
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Assessment method [9]
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Health economic analysis consisting of medical resource utilization (MRU) between the interrogation and deferred interrogation arms. A patient diary will be used to assess the rate of medical resource use (i.e. hospital, urgent care, office visits related to treatment of the study ulcer).
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Timepoint [9]
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up to 24 months
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Eligibility
Key inclusion criteria
- Be between 18 and 85 years of age.
- Able and willing to participate and comply with the protocol, including the defined
follow-up schedule, by signing an Institutional Review Board (IRB) or Ethics Committee
approved informed consent form.
- Active venous leg ulcer (CEAP C6).
- Previously completed treatment for clinically significant reflux in the superficial
and/or perforator venous system of the target limb at least 3 months prior to
enrollment, if clinically indicated.
- Completed at least 3 months of prescribed compression therapy after any ablation.
- Palpable dorsalis pedis or posterior tibial artery (DP/PT) pulses at ipsilateral foot
or ankle brachial index (ABI) =0.8.
- Be able to ambulate unassisted or with non-motorized assistive devices.
- Current VLU present =48 months.
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Minimum age
18
Years
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patient is known pregnant or breast-feeding or planning to become pregnant in the
following year.
- If antiplatelet and anticoagulation therapy cannot be tolerated.
- Previous venous stent implantation involving the target limb, target lesion, or
inferior vena cava.
- Previous venovenous bypass surgery involving the target limb.
- Previous endovascular recanalization of the target lesion segment.
- Known metal allergy precluding stent implantation.
- Known or suspected to have inadequate inflow to support stent patency in the target
limb.
- Active cancer diagnosis.
- Known positive test for COVID-19 (Sars-CoV-2) within the last 2 weeks and actively
symptomatic.
- Known or suspected venous outflow obstruction caused by tumor compression/encasement
with or without thrombus.
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study
procedure.
- Known renal dysfunction (defined as eGFR <30mL/min/1.73m2) that would preclude
adequate contrast usage.
- Diagnosed with right heart failure/pulmonary hypertension.
- Has known clinically significant abnormal platelet count outside laboratory reference
ranges.
- Has known clinically significant abnormal white blood cell count (WBC), fever, sepsis
or positive blood culture.
- Organ transplant requiring immunosuppressant therapy.
- Unstable angina pectoris, or myocardial infarction within 30 days and/or hemorrhagic
stroke within 3 months.
- Subjects with an active diagnosis of osteomyelitis of the ipsilateral limb.
- Previous or planned surgical or catheter-based procedure on index leg within 30 days
before or 30 days after the index procedure.
- Active participation in another investigational drug or device study.
- Subject has any condition, which, in the opinion of the investigator, precludes the
subject from participation.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/01/2023
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Sample size
Target
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Accrual to date
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Final
12
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Wollongong Hospital - Wollongong
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Recruitment hospital [2]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2500 - Wollongong
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Recruitment postcode(s) [2]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Connecticut
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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Louisiana
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Country [5]
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United States of America
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State/province [5]
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New Jersey
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Country [6]
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United States of America
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State/province [6]
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New York
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Country [7]
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United States of America
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State/province [7]
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North Carolina
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Country [8]
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France
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State/province [8]
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Alsace
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Country [9]
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France
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State/province [9]
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Bourbonnais
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Country [10]
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France
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State/province [10]
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Dijon
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Country [11]
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Germany
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State/province [11]
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North Rhine-Westphalia
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Country [12]
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United Kingdom
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State/province [12]
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London
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Country [13]
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United Kingdom
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State/province [13]
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Hampstead
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Philips Clinical & Medical Affairs Global
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This clinical study is a global, prospective, multi-center, randomized controlled trial to
determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and
as an interventional treatment guide will result in a more accurate diagnosis of deep vein
occlusion (DVO), will guide optimal therapy, and will provide better clinical outcomes with
reduced cost of care for patients presenting with persistent venous leg ulcers (VLUs).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04696354
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen Black, MD
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Address
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St. Thomas and Guys Hospital
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04696354
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