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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04696354




Registration number
NCT04696354
Ethics application status
Date submitted
14/12/2020
Date registered
6/01/2021
Date last updated
25/01/2023

Titles & IDs
Public title
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
Scientific title
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers
Secondary ID [1] 0 0
200202
Secondary ID [2] 0 0
IGT_IGD_VLU_2020_10876
Universal Trial Number (UTN)
Trial acronym
IGuideU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Ulcer of Leg 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - IVUS
Other interventions - Continued Compression Therapy/Stockings

Other: Interrogation Arm - 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.

Other: Deferred Interrogation Arm - 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.


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

Other interventions: Continued Compression Therapy/Stockings
Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed.
Intervention code [1] 0 0
Diagnosis / Prognosis
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of detection and difference in complete ulcer healing between the interrogation group and the deferred interrogation group
Timepoint [1] 0 0
3 Months
Primary outcome [2] 0 0
Composite of the difference in deep venous obstruction (DVO) detection and the subsequent changes in treatment plan informed by IVUS compared to MPV.
Timepoint [2] 0 0
24 months
Secondary outcome [1] 0 0
Rate of Ulcer healing measured
Timepoint [1] 0 0
3,6,12,18, and 24 months
Secondary outcome [2] 0 0
Rate of Ulcer healing for stented patients
Timepoint [2] 0 0
3,6,12,18, and 24 months
Secondary outcome [3] 0 0
Rate of recurring ulcers in both arms
Timepoint [3] 0 0
3-24 months
Secondary outcome [4] 0 0
Rate of recurring ulcers between post-thrombotic syndrome and non-thrombotic iliac vein lesion patients
Timepoint [4] 0 0
up to 24 months
Secondary outcome [5] 0 0
Change in Quality of Life scores using the EQ5D-5L as compared in both arms
Timepoint [5] 0 0
up to 24 months
Secondary outcome [6] 0 0
Change in Quality of Life scores using the 36 Item Short Form question assessment as compared in both arms
Timepoint [6] 0 0
up to 24 months
Secondary outcome [7] 0 0
Change in clinical score using the Venous Ulcer Assessment (VCSS)
Timepoint [7] 0 0
up to 24 months
Secondary outcome [8] 0 0
Change in clinical classification using the Clinical Etiology and Anatomy Pathology classification system
Timepoint [8] 0 0
up to 24 months
Secondary outcome [9] 0 0
Rate of medical resource utilization between the interrogation arm and deferred interrogation arms
Timepoint [9] 0 0
up to 24 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/01/2023
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
France
State/province [8] 0 0
Alsace
Country [9] 0 0
France
State/province [9] 0 0
Bourbonnais
Country [10] 0 0
France
State/province [10] 0 0
Dijon
Country [11] 0 0
Germany
State/province [11] 0 0
North Rhine-Westphalia
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Hampstead

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Philips Clinical & Medical Affairs Global
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04696354
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Black, MD
Address 0 0
St. Thomas and Guys Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04696354