Venous Ulcer of LegIGuideUNCT04696354
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
A study testing IVUS and Continued Compression Therapy/Stockings in people with Venous Ulcer of Leg, run by Philips Clinical & Medical Affairs Global at 17 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Venous Ulcer of Leg
- What is being tested?
- IVUS and Continued Compression Therapy/Stockings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 12 Oct 2021to 17 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States8 sites
Atrium Health
Charlotte, North Carolina, 28210
Northwestern
Chicago, Illinois, 60208
Vascular Care Connecticut
Darien, Connecticut, 06820
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Cardiovascular Institute of the South
Houma, Louisiana, 70394
Vein Center of Southwest Louisiana
Lake Charles, Louisiana, 70601
NYU Langone Health
New York, New York, 10016
Florida Cardiology, P.A.
Winter Park, Florida, 32792
France3 sites
C.H.U. Dijon
Dijon, 77908
CHU Strasbourg
Strasbourg, Alsace, 67000
CH Vichy
Vichy, Bourbonnais, 03200
United Kingdom3 sites
Royal Free London NHS Foundation Trust
Hampstead
Northwick Park Hospital
Harrow, London, HA1 3UJ
Guys and St. Thomas' Hospital
London
Australia2 sites
Royal Perth Hospital
Perth, Western Australia, 6000
Wollongong Hospital
Wollongong, New South Wales, 2500
Germany1 site
Klinikum Hochsauerland GmbH
Arnsberg, North Rhine-Westphalia, 59755
About this study
Official title: Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers
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).
Read the 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
- Being tested
- IVUS, Continued Compression Therapy/Stockings
- Keywords
- VLU, venous leg ulcer, ulcer, venous leg wound, venous stenting, IVUS, DVO
- Medical subject headings
- Varicose Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUSDiagnostic test
Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan.
Continued Compression Therapy/StockingsOther
Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed.
| Study group | Role | What they receive |
|---|---|---|
| Interrogation Arm | Other | 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. Receives: Diagnostic Test: IVUS |
| Deferred Interrogation Arm | Other | 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. Receives: Other: Continued Compression Therapy/Stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start12 Oct 2021
- Primary completion11 Jan 2023
- Study completion17 Jan 2023
Why it stopped: The study was stopped due to ongoing enrollment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous Ulcer of LegStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Black, MD, Principal investigator, St. Thomas and Guys HospitalPaul Gagne, MD, Principal investigator, Vascular Care CT, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696354
- Sponsor's protocol ID
- IGT_IGD_VLU_2020_10876
- Other IDs
- 200202
- Acronym
- IGuideU
- Status last verified
- Nov 2026
- First submitted
- 14 Dec 2020
- Last updated
- 3 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT04696354
- Acronym / sponsor ID
- IGuideU / IGT_IGD_VLU_2020_10876
- Conditions
- Venous Ulcer of Leg
- Keywords
- VLU, venous leg ulcer, ulcer, venous leg wound, venous stenting, IVUS, DVO
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to ongoing enrollment challenges.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interrogation Arm | Other | Diagnostic Test: IVUSpatients 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 Arm | Other | Other: Continued Compression Therapy/StockingsDeferred 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUSThose who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan. | Diagnostic test | Interrogation Arm |
| Continued Compression Therapy/StockingsThose who are randomized to the deferred interrogation arm while continue compression therapy as prescribed. | Other | Deferred Interrogation Arm |
Primary outcome
Rate of Detection and Difference in Complete Ulcer Healing Between the Interrogation Group and the Deferred Interrogation Group
Time frame: 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Black, MD principal investigator
St. Thomas and Guys Hospital
Paul Gagne, MD principal investigator
Vascular Care CT, PLLC
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS and Continued Compression Therapy/Stockings in people with Venous Ulcer of Leg, run by Philips Clinical & Medical Affairs Global at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, France, United Kingdom, Australia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Detection and Difference in Complete Ulcer Healing Between the Interrogation Group and the Deferred Interrogation Group (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.