NCT04696354

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

Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed 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

Conditions

• Venous Ulcer of Leg

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-12
• Primary completion: 2023-01-11
• Completion: 2023-01-17
• First posted: 2021-01-06
• Last updated: 2024-10-01
• Results posted: 2024-10-01

Locations

17 sites across 5 countries: United States, Australia, France, Germany, United Kingdom

Regulatory

• FDA-regulated device study