NCT04696354: IGuideU

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

Terminated NA Results posted Last updated 1 October 2024

What this trial tests

NA trial testing IVUS in Venous Ulcer of Leg in 12 participants. Terminated before completion.

Timeline

12 October 2021

Primary endpoint
11 January 2023

17 January 2023

Quick facts

Lead sponsor	Philips Clinical & Medical Affairs Global
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	12
Start date	12 October 2021
Primary completion	11 January 2023
Estimated completion	17 January 2023
Sites	17 locations across France, United Kingdom, Germany, Australia, United States

Drugs / interventions tested

• IVUS
• Continued Compression Therapy/Stockings

Conditions studied

• Venous Ulcer of Leg — all drugs for Venous Ulcer of Leg →

Sponsor

Philips Clinical & Medical Affairs Global — full company profile →

Who can join

Adults 18 to 85, any sex, with Venous Ulcer of Leg. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Appropriate Use of Intravascular Ultrasound During Arterial and Venous Lower Extremity Interventions.
   Secemsky EA, Mosarla RC, Rosenfield K, Kohi M, et al · · 2022 · cited 32× · PMID 35926922 · DOI 10.1016/j.jcin.2022.04.034