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

NCT04696354 | Terminated Results FDA Device

• 2 other identifiers: IGT_IGD_VLU_2020_10876200202
• Study Type: interventional
• Target: 12
• Locations: 5 countries
• Sites: 17

Brief 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).

Conditions

Venous Ulcer of Leg

Keywords

VLU; venous leg ulcer; ulcer; venous leg wound; venous stenting; IVUS; DVO

Outcome Measures

Primary Outcomes (1)

• Rate of Detection and Difference in Complete Ulcer Healing Between the Interrogation Group and the Deferred Interrogation Group

  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

Study Arms (2)

Interrogation Arm

OTHER

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.

Diagnostic Test: IVUS

Deferred Interrogation Arm

OTHER

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.

Other: Continued Compression Therapy/Stockings

Interventions

IVUS DIAGNOSTIC_TEST

Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan.

Interrogation Arm

Continued Compression Therapy/Stockings OTHER

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

Deferred Interrogation Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (17)

Vascular Care Connecticut

Darien, Connecticut, 06820, United States

Location

Florida Cardiology, P.A.

Winter Park, Florida, 32792, United States

Location

Northwestern

Chicago, Illinois, 60208, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70394, United States

Location

Vein Center of Southwest Louisiana

Lake Charles, Louisiana, 70601, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Atrium Health

Charlotte, North Carolina, 28210, United States

Location

Wollongong Hospital

Wollongong, New South Wales, 2500, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

CHU Strasbourg

Strasbourg, Alsace, 67000, France

Location

CH Vichy

Vichy, Bourbonnais, 03200, France

Location

C.H.U. Dijon

Dijon, 77908, France

Location

Klinikum Hochsauerland GmbH

Arnsberg, North Rhine-Westphalia, 59755, Germany

Location

Northwick Park Hospital

Harrow, London, HA1 3UJ, United Kingdom

Location

Royal Free London NHS Foundation Trust

Hampstead, United Kingdom

Location

Guys and St. Thomas' Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was terminated due to slow enrollment, only 12 of 266 subjects have been enrolled. Because enrollment in this clinical trial did not reach the target number of subjects needed to achieve target power, no data was collected. No statistical analysis information will be submitted for the outcome measures.

Results Point of Contact

• Title: Danielle Op den Kamp, Sr Manager Clinical Operations
• Organization: Philips

Danielle.op.den.kamp@philips.com

+31 (0)627218737

Study Officials

• Stephen Black, MD

  St. Thomas and Guys Hospital

  PRINCIPAL INVESTIGATOR

• Paul Gagne, MD

  Vascular Care CT, PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 6, 2021
• Study Start: October 12, 2021
• Primary Completion: January 11, 2023
• Study Completion: January 17, 2023
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); US (8); FR (3); GB (3); AU (2)