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Intravaskulær ultralyds-guidet intervention for venøse bensår (IGuideU) (IGuideU)

2. november 2026 opdateret af: Philips Clinical & Medical Affairs Global

Intravaskulær ultralyds-guidet intervention for venøse bensår

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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Diagnostisk test: IVUS

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

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Detection and Difference in Complete Ulcer Healing Between the Interrogation Group and the Deferred Interrogation Group
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Philips Clinical & Medical Affairs Global

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. oktober 2021

Primær færdiggørelse (Faktiske)

11. januar 2023

Studieafslutning (Faktiske)

17. januar 2023

Datoer for studieregistrering

Først indsendt

14. december 2020

Først indsendt, der opfyldte QC-kriterier

4. januar 2021

Først opslået (Faktiske)

6. januar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IGT_IGD_VLU_2020_10876
  • 200202 (Anden identifikator: IGTD Protocol no.)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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