IGuideU, protocol no.200202
Research type
Research Study
Full title
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
IRAS ID
291885
Contact name
Danielle Op den Kamp
Contact email
Sponsor organisation
Philips Image Guided Therapy Devices
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 8 months, 31 days
Research summary
This study is to comparing 2 different treatment strategies for patients with a venous leg ulcer. The goal is to determine whether the interrogation of the deep venous system for deep venous obstruction by venography plus intravascular ultrasound (IVUS), with potential interventional treatment guided by IVUS, results in improved clinical outcomes when compared to deferred interrogation of the deep venous system.
Patients will be randomized 1:1:
-In the interrogation arm patients will be evaluated with venography (limited to 3 views) and the treatment plan based on the venographic results will be documented. Then patients will be evaluated using IVUS and a treatment plan based on IVUS results will be documented. Any patients determined to require venous stenting based on IVUS results will be stented accordingly using IVUS to guide stent placement.
-In the deferred interrogation arm patients will continue their non-invasive wound care with compression therapy and wound dressings.In both arms patients will be followed-up for 24 months to monitor the healing of the leg ulcer. Patients that experience non-healing wounds in the deferred interrogation arm are allowed to cross-over to the interrogation arm after 3 months in the study. They will then receive the treatment as described in the interrogation arm.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
21/LO/0354
Date of REC Opinion
24 Jun 2021
REC opinion
Further Information Favourable Opinion