Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)

Stopped early · Not applicable

Conditions studied: Venous Ulcer of Leg

In brief

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).

Key facts

Study ID

NCT04696354

Run by

Philips Clinical & Medical Affairs Global

People needed

12

Starts

2021-10-12

Expected to finish

2023-01-17

Last updated by the study team

2024-10-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Vascular Care Connecticut — Darien, Connecticut, United States
• Florida Cardiology, P.A. — Winter Park, Florida, United States
• Northwestern — Chicago, Illinois, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• Vein Center of Southwest Louisiana — Lake Charles, Louisiana, United States
• Englewood Hospital and Medical Center — Englewood, New Jersey, United States
• NYU Langone Health — New York, New York, United States
• Atrium Health — Charlotte, North Carolina, United States
• Wollongong Hospital — Wollongong, New South Wales, Australia
• Royal Perth Hospital — Perth, Western Australia, Australia
• CHU Strasbourg — Strasbourg, Alsace, France
• CH Vichy — Vichy, Bourbonnais, France
• C.H.U. Dijon — Dijon, France
• Klinikum Hochsauerland GmbH — Arnsberg, North Rhine-Westphalia, Germany
• Northwick Park Hospital — Harrow, London, United Kingdom
• Royal Free London NHS Foundation Trust — Hampstead, United Kingdom
• Guys and St. Thomas' Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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