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Intervento intravascolare guidato da ultrasuoni per ulcere venose delle gambe (IGuideU) (IGuideU)

2 novembre 2026 aggiornato da: Philips Clinical & Medical Affairs Global

Intervento intravascolare guidato da ultrasuoni per ulcere venose delle gambe

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).

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

12

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • Wollongong Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Francia
      • Dijon, Francia, 77908
        • C.H.U. Dijon
    • Alsace
      • Strasbourg, Alsace, Francia, 67000
        • CHU Strasbourg
    • Bourbonnais
      • Vichy, Bourbonnais, Francia, 03200
        • CH Vichy
  • Germania
    • North Rhine-Westphalia
      • Arnsberg, North Rhine-Westphalia, Germania, 59755
        • Klinikum Hochsauerland GmbH
  • Regno Unito
      • Hampstead, Regno Unito
        • Royal Free London NHS Foundation Trust
      • London, Regno Unito
        • Guys and St. Thomas' Hospital
    • London
      • Harrow, London, Regno Unito, HA1 3UJ
        • Northwick Park Hospital
  • Stati Uniti
    • Connecticut
      • Darien, Connecticut, Stati Uniti, 06820
        • Vascular Care Connecticut
    • Florida
      • Winter Park, Florida, Stati Uniti, 32792
        • Florida Cardiology, P.A.
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60208
        • Northwestern
    • Louisiana
      • Houma, Louisiana, Stati Uniti, 70394
        • Cardiovascular Institute of the South
      • Lake Charles, Louisiana, Stati Uniti, 70601
        • Vein Center of Southwest Louisiana
    • New Jersey
      • Englewood, New Jersey, Stati Uniti, 07631
        • Englewood Hospital and Medical Center
    • New York
      • New York, New York, Stati Uniti, 10016
        • NYU Langone Health
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti, 28210
        • Atrium Health

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.
Test diagnostico: IVUS

Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan.
Altro: 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.
Altro: Continued Compression Therapy/Stockings

Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rate of Detection and Difference in Complete Ulcer Healing Between the Interrogation Group and the Deferred Interrogation Group
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Philips Clinical & Medical Affairs Global

Investigatori

  • Investigatore principale: Stephen Black, MD, St. Thomas and Guys Hospital
  • Investigatore principale: Paul Gagne, MD, Vascular Care CT, PLLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 ottobre 2021

Completamento primario (Effettivo)

11 gennaio 2023

Completamento dello studio (Effettivo)

17 gennaio 2023

Date di iscrizione allo studio

Primo inviato

14 dicembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

4 gennaio 2021

Primo Inserito (Effettivo)

6 gennaio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IGT_IGD_VLU_2020_10876
  • 200202 (Altro identificatore: IGTD Protocol no.)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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