Venous Ulcer of Leg
Conditions
Keywords
VLU, venous leg ulcer, ulcer, venous leg wound, venous stenting, IVUS, DVO
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
Interventions
DIAGNOSTIC_TESTIVUS
Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan.
OTHERContinued Compression Therapy/Stockings
Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed.
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Detection and Difference in Complete Ulcer Healing Between the Interrogation Group and the Deferred Interrogation Group | 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. |
Countries
Australia, France, Germany, United Kingdom, United States
Participant flow
Recruitment details
No analysis performed. Study was terminated due to slow enrollment. Only 12 enrollments of the required 266 subjects.
Pre-assignment details
For the small number of enrolled patients no data was collected for analysis. No outcome measures to report.
Participants by arm
| Arm | Count |
|---|---|
| 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.
IVUS: Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan. | 6 |
| 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.
Continued Compression Therapy/Stockings: Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study termination | 6 | 6 |
Baseline characteristics
| Characteristic | — | Total | Deferred Interrogation Arm | Interrogation Arm |
|---|---|---|---|---|
| Age, Continuous | — years | — | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | — | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment France | — | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United Kingdom | — | 8 participants | 4 participants | 4 participants |
| Region of Enrollment United States | — | 3 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | — | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | — | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 3 months
Population: No data was collected for analysis. No outcome data to report.