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

  • STATUS
    Recruiting
  • End date
    Nov 13, 2026
  • participants needed
    266
  • sponsor
    Philips Clinical & Medical Affairs Global
Updated on 13 October 2022

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).

Description

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

Details
Condition Venous Ulcer of Leg
Treatment IVUS, Continued Compression Therapy/Stockings
Clinical Study IdentifierNCT04696354
SponsorPhilips Clinical & Medical Affairs Global
Last Modified on13 October 2022

Eligibility

Yes No Not Sure

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 renal dysfunction (defined as eGFR <30mL/min/1.73m2) that would preclude adequate contrast usage
Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure
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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