search
Back to results

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

Primary Purpose

Venous Ulcer of Leg

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
IVUS
Continued Compression Therapy/Stockings
Sponsored by
Philips Clinical & Medical Affairs Global
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Venous Ulcer of Leg focused on measuring VLU, venous leg ulcer, ulcer, venous leg wound, venous stenting, IVUS, DVO

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Organ transplant requiring immunosuppressant therapy.
  • Unstable angina pectoris, or myocardial infarction within 30 days and/or hemorrhagic stroke within 3 months.
  • Subjects with an active diagnosis of osteomyelitis of the ipsilateral limb.
  • Previous or planned surgical or catheter-based procedure on index leg within 30 days before or 30 days after the index procedure.
  • Active participation in another investigational drug or device study.
  • Subject has any condition, which, in the opinion of the investigator, precludes the subject from participation.

Sites / Locations

  • Vascular Care Connecticut
  • Florida Cardiology, P.A.
  • Northwestern
  • Cardiovascular Institute of the South
  • Vein Center of Southwest Louisiana
  • Englewood Hospital and Medical Center
  • NYU Langone Health
  • Atrium Health
  • Wollongong Hospital
  • Royal Perth Hospital
  • CHU Strasbourg
  • CH Vichy
  • C.H.U. Dijon
  • Klinikum Hochsauerland GmbH
  • Northwick Park Hospital
  • Royal Free London NHS Foundation Trust
  • Guys and St. Thomas' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Interrogation Arm

Deferred Interrogation Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Composite of the difference in deep venous obstruction (DVO) detection and the subsequent changes in treatment plan informed by IVUS compared to MPV.
Composite of the difference in DVO detection and the subsequent changes in treatment plan informed by IVUS compared to multiplanar venography (MPV). DVO is defined as ≥50% diameter reduction in the deep venous system as assessed by MPV or ≥50% reduction in cross-section area of the deep venous system assessed by IVUS. Changes in treatment plan will be assessed by use of a patient diary and follow up patient visits up to 24 months.

Secondary Outcome Measures

Rate of Ulcer healing measured
Rate of ulcer healing measured between groups at 3,6,12,18, and 24 months
Rate of Ulcer healing for stented patients
Rate of ulcer healing for stented post-thrombotic syndrome (PTS) and non-thrombotic iliac vein lesion (NIVL) patients at 3,6,12,18, and 24 months
Rate of recurring ulcers in both arms
Rate recurring ulcers in both arms from 3 months out to follow-up visit 24 months provided each arm has at least 30 subjects. The choice of 30 is based on central limit theorem in order to have normally distributed data for descriptive summary statistics.
Rate of recurring ulcers between post-thrombotic syndrome and non-thrombotic iliac vein lesion patients
Rate of recurring ulcers between PTS and NIVL sub-groups
Change in Quality of Life scores using the EQ5D-5L as compared in both arms
Change in QOL scores for both arms using the EQ5D-5L. The scale uses a scoring system of 0-100. Each response is assigned a number 1-5 and then added at the end to equal a number between 0-100. The higher the total, the better the score.
Change in Quality of Life scores using the 36 Item Short Form question assessment as compared in both arms
Change in QOL scores for both arms using the 36 Item Short Form question assessment. The responses are coded using a scoring key, then averaged to get a final score in each of the 8 categories utilized on the assessment. Items are scored ranging from 0-100. The higher the average, the better the score.
Change in clinical score using the Venous Ulcer Assessment (VCSS)
Change in clinical score will be assessed using the VCSS. The VCSS consists of 10 questions, each response is scored on a scale of 0-3. The total score ranges between 0-30 and is used to assess changes in disease severity over time. A lower score is a better outcome.
Change in clinical classification using the Clinical Etiology and Anatomy Pathology classification system
Change in clinical classification will be assessed using the Clinical Etiology and Anatomy Pathology (CEAP) scoring system. The system is designed to classify chronic venous disease. The clinical classification consists of 7 possibilities, ranging from 0-6, followed by sub categories to assign 1)symptoms, 2) etiologic classification, 3) anatomic classification, 4)pathophysiologic, and 5) anatomic segment classification. The lower the clinical classification score, the less severe the disease state.
Rate of medical resource utilization between the interrogation arm and deferred interrogation arms
Health economic analysis consisting of medical resource utilization (MRU) between the interrogation and deferred interrogation arms. A patient diary will be used to assess the rate of medical resource use (i.e. hospital, urgent care, office visits related to treatment of the study ulcer).

Full Information

First Posted
December 14, 2020
Last Updated
January 20, 2023
Sponsor
Philips Clinical & Medical Affairs Global
search

1. Study Identification

Unique Protocol Identification Number
NCT04696354
Brief Title
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
Acronym
IGuideU
Official Title
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to ongoing enrollment challenges.
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
January 11, 2023 (Actual)
Study Completion Date
January 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Clinical & Medical Affairs Global

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcer of Leg
Keywords
VLU, venous leg ulcer, ulcer, venous leg wound, venous stenting, IVUS, DVO

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interrogation Arm
Arm Type
Other
Arm Description
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.
Arm Title
Deferred Interrogation Arm
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
IVUS
Intervention Description
Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan.
Intervention Type
Other
Intervention Name(s)
Continued Compression Therapy/Stockings
Intervention Description
Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed.
Primary Outcome Measure Information:
Title
Rate of detection and difference in complete ulcer healing between the interrogation group and the deferred interrogation group
Description
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.
Time Frame
3 Months
Title
Composite of the difference in deep venous obstruction (DVO) detection and the subsequent changes in treatment plan informed by IVUS compared to MPV.
Description
Composite of the difference in DVO detection and the subsequent changes in treatment plan informed by IVUS compared to multiplanar venography (MPV). DVO is defined as ≥50% diameter reduction in the deep venous system as assessed by MPV or ≥50% reduction in cross-section area of the deep venous system assessed by IVUS. Changes in treatment plan will be assessed by use of a patient diary and follow up patient visits up to 24 months.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Rate of Ulcer healing measured
Description
Rate of ulcer healing measured between groups at 3,6,12,18, and 24 months
Time Frame
3,6,12,18, and 24 months
Title
Rate of Ulcer healing for stented patients
Description
Rate of ulcer healing for stented post-thrombotic syndrome (PTS) and non-thrombotic iliac vein lesion (NIVL) patients at 3,6,12,18, and 24 months
Time Frame
3,6,12,18, and 24 months
Title
Rate of recurring ulcers in both arms
Description
Rate recurring ulcers in both arms from 3 months out to follow-up visit 24 months provided each arm has at least 30 subjects. The choice of 30 is based on central limit theorem in order to have normally distributed data for descriptive summary statistics.
Time Frame
3-24 months
Title
Rate of recurring ulcers between post-thrombotic syndrome and non-thrombotic iliac vein lesion patients
Description
Rate of recurring ulcers between PTS and NIVL sub-groups
Time Frame
up to 24 months
Title
Change in Quality of Life scores using the EQ5D-5L as compared in both arms
Description
Change in QOL scores for both arms using the EQ5D-5L. The scale uses a scoring system of 0-100. Each response is assigned a number 1-5 and then added at the end to equal a number between 0-100. The higher the total, the better the score.
Time Frame
up to 24 months
Title
Change in Quality of Life scores using the 36 Item Short Form question assessment as compared in both arms
Description
Change in QOL scores for both arms using the 36 Item Short Form question assessment. The responses are coded using a scoring key, then averaged to get a final score in each of the 8 categories utilized on the assessment. Items are scored ranging from 0-100. The higher the average, the better the score.
Time Frame
up to 24 months
Title
Change in clinical score using the Venous Ulcer Assessment (VCSS)
Description
Change in clinical score will be assessed using the VCSS. The VCSS consists of 10 questions, each response is scored on a scale of 0-3. The total score ranges between 0-30 and is used to assess changes in disease severity over time. A lower score is a better outcome.
Time Frame
up to 24 months
Title
Change in clinical classification using the Clinical Etiology and Anatomy Pathology classification system
Description
Change in clinical classification will be assessed using the Clinical Etiology and Anatomy Pathology (CEAP) scoring system. The system is designed to classify chronic venous disease. The clinical classification consists of 7 possibilities, ranging from 0-6, followed by sub categories to assign 1)symptoms, 2) etiologic classification, 3) anatomic classification, 4)pathophysiologic, and 5) anatomic segment classification. The lower the clinical classification score, the less severe the disease state.
Time Frame
up to 24 months
Title
Rate of medical resource utilization between the interrogation arm and deferred interrogation arms
Description
Health economic analysis consisting of medical resource utilization (MRU) between the interrogation and deferred interrogation arms. A patient diary will be used to assess the rate of medical resource use (i.e. hospital, urgent care, office visits related to treatment of the study ulcer).
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Organ transplant requiring immunosuppressant therapy. Unstable angina pectoris, or myocardial infarction within 30 days and/or hemorrhagic stroke within 3 months. Subjects with an active diagnosis of osteomyelitis of the ipsilateral limb. Previous or planned surgical or catheter-based procedure on index leg within 30 days before or 30 days after the index procedure. Active participation in another investigational drug or device study. Subject has any condition, which, in the opinion of the investigator, precludes the subject from participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Black, MD
Organizational Affiliation
St. Thomas and Guys Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Gagne, MD
Organizational Affiliation
Vascular Care CT, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vascular Care Connecticut
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
Florida Cardiology, P.A.
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Northwestern
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70394
Country
United States
Facility Name
Vein Center of Southwest Louisiana
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Wollongong Hospital
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
CHU Strasbourg
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67000
Country
France
Facility Name
CH Vichy
City
Vichy
State/Province
Bourbonnais
ZIP/Postal Code
03200
Country
France
Facility Name
C.H.U. Dijon
City
Dijon
ZIP/Postal Code
77908
Country
France
Facility Name
Klinikum Hochsauerland GmbH
City
Arnsberg
State/Province
North Rhine-Westphalia
ZIP/Postal Code
59755
Country
Germany
Facility Name
Northwick Park Hospital
City
Harrow
State/Province
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
Hampstead
Country
United Kingdom
Facility Name
Guys and St. Thomas' Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs