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

NCT04696354 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-10-01

Study results available
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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

Interventions

DIAGNOSTIC_TEST

IVUS

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

OTHER

Continued Compression Therapy/Stockings

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

Sponsors & Collaborators

  • Philips Clinical & Medical Affairs Global

    lead INDUSTRY

Principal Investigators

  • Stephen Black, MD · St. Thomas and Guys Hospital

  • Paul Gagne, MD · Vascular Care CT, PLLC

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2023-01-11
Completion
2023-01-17
FDA Device
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04696354 on ClinicalTrials.gov