An interventional study of IVUS and Continued Compression Therapy/Stockings in Venous Ulcer of Leg, sponsored by Philips Clinical & Medical Affairs Global. Terminated at 17 sites in 5 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Philips Clinical & Medical Affairs Global (part of Philips) · Not applicable, Interventional, and Diagnostic
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).
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
384 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's enrollment of 12 is below the median of 64 across 329 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Philips Clinical & Medical Affairs Global is the lead sponsor of 84 studies on the registry; 24 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
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Exclusion Criteria:
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.
Diagnostic Test: IVUS
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.
Other: Continued Compression Therapy/Stockings
Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan.
Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed.
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
No analysis performed. Study was terminated due to slow enrollment. Only 12 enrollments of the required 266 subjects.
| Milestone | Interrogation Arm | Deferred Interrogation Arm |
|---|---|---|
| Started | 6 | 6 |
| Completed | 0 | 0 |
| Not completed | 6 | 6 |
| Withdrew: Study termination | 6 | 6 |
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.
No measurements were reported for this outcome.
Collected over This study was terminated due to slow enrollment, only 12 of 266 subjects were enrolled. No data was collected for statistical analysis.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interrogation Arm | — | — | — |
| Deferred Interrogation Arm | — | — | — |
No data collected for analysis.
| Age, Continuous(years) | Interrogation Arm | Deferred Interrogation Arm | Total |
|---|
| Sex: Female, Male(Participants) | Interrogation Arm | Deferred Interrogation Arm | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Interrogation Arm | Deferred Interrogation Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Interrogation Arm | Deferred Interrogation Arm | Total |
|---|---|---|---|
| United States | 2 | 1 | 3 |
| United Kingdom | 4 | 4 | 8 |
| France | 1 | 0 | 1 |
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Plan to share: No
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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