Intervención guiada por ultrasonido intravascular para úlceras venosas de la pierna (IGuideU) (IGuideU)
Intervención guiada por ecografía intravascular para las úlceras venosas de la pierna
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will be conducted in 266 subjects presenting with venous ulcers that have previously undergone treatment for superficial of and/or perforator venous disease, if clinically indicated, followed by at least 3 months of prescribed compression therapy prior to screening.
There are 6 study visits for each subject that will be completed over a period lasting approximately 24 months. Subjects will undergo a baseline/screening assessment (visit 1) followed by an interrogation procedure (visit 2) if the subject is enrolled into the interrogation arm. If the subject is randomized to the deferred interrogation arm, he/she will have a hospital/office visit in lieu of the interrogation procedure, which will be considered visit 2. For statistical purposes, the wound assessment performed at the index procedure/hospital visit will be considered the baseline measurement. 30±14 days and 90±14 days after Visit 2, the subject will return to the office for a 1- and 3-month follow-up visit, respectively. The subjects will return at 6- and 12-months post-index procedure/Visit 2 for follow-up assessments. The follow-up period for this study will be approximately 24 months, with a phone call only at 24-months post-index procedure/visit 2.
The clinical study has a planned enrollment period of 36 months and a planned study duration period of 5.17 years
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Rhine-Westphalia
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Arnsberg, North Rhine-Westphalia, Alemania, 59755
- Klinikum Hochsauerland GmbH
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New South Wales
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Wollongong, New South Wales, Australia, 2500
- Wollongong Hospital
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Western Australia
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Perth, Western Australia, Australia, 6000
- Royal Perth Hospital
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Connecticut
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Darien, Connecticut, Estados Unidos, 06820
- Vascular Care Connecticut
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Florida
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Winter Park, Florida, Estados Unidos, 32792
- Florida Cardiology, P.A.
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Illinois
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Chicago, Illinois, Estados Unidos, 60208
- Northwestern
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Louisiana
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Houma, Louisiana, Estados Unidos, 70394
- Cardiovascular Institute of the South
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Lake Charles, Louisiana, Estados Unidos, 70601
- Vein Center of Southwest Louisiana
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New Jersey
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Englewood, New Jersey, Estados Unidos, 07631
- Englewood Hospital and Medical Center
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New York
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New York, New York, Estados Unidos, 10016
- NYU Langone Health
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28210
- Atrium Health
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Dijon, Francia, 77908
- C.H.U. Dijon
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Alsace
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Strasbourg, Alsace, Francia, 67000
- CHU Strasbourg
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Bourbonnais
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Vichy, Bourbonnais, Francia, 03200
- CH Vichy
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Hampstead, Reino Unido
- Royal Free London NHS Foundation Trust
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London, Reino Unido
- Guys and St. Thomas' Hospital
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London
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Harrow, London, Reino Unido, HA1 3UJ
- Northwick Park Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: 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. |
Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan. |
|
Otro: Deferred Interrogation Arm
Deferred Interrogation Guidelines for this study are as follows: Mandate: • Continued compression therapy/stockings as prescribed. Allow:
Prohibit:
|
Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of Detection and Difference in Complete Ulcer Healing Between the Interrogation Group and the Deferred Interrogation Group
Periodo de tiempo: 3 months
|
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. |
3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stephen Black, MD, St. Thomas and Guys Hospital
- Investigador principal: Paul Gagne, MD, Vascular Care CT, PLLC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IGT_IGD_VLU_2020_10876
- 200202 (Otro identificador: IGTD Protocol no.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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