PICO Venous Leg Ulcers (VLU) Reimbursement Study (NCT06510777) | Clinical Trial Compass
TerminatedNot Applicable
PICO Venous Leg Ulcers (VLU) Reimbursement Study
Stopped: Early terminated due to protocol design issues with inability to correct at this stage.
France142 participantsStarted 2023-12-29
Plain-language summary
This study intends to demonstrate the superiority of PICO treatment when applied up to 12 weeks, versus Standard of Care (SOC) in the treatment of hard to heal Venous Leg Ulcers (VLU) by community-based practitioners. The primary endpoint is the incidence of confirmed healed VLUs at 12 weeks or before, in the PICO treatment group versus the SOC group. The study hypothesis is based on the Kirsner study (Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities. Wound Repair Regen. 2019 Sep;27(5):519-529)), which compared PICO treatment to traditional NPWT (t-NPWT); the ITT analysis in the subgroup of patients with VLU showed 45.1% wound closure (confirmed wound healing) at 12 weeks in the PICO group as compared to 28% in the t-NPWT group, yielding a difference of 17.1%, 95% Confidence Interval = (-1.9%;+35.4%). For our study, the Sponsor made the assumptions that the t-NPWT healing proportion (28%) can be used as conservative estimate for the control group proportion and that the PICO group should provide at least a 17% improvement over standard of care. Adaptative design is chosen to adjust the sample size using the re-assessment size method to preserve alpha risk (α) level.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject signed informed consent
* Both gender adult ≥ 18 years old
* Venous leg ulcer (VLU) diagnosed by:
* ABPI ≥ 0.7 and \< 1.3 within the last 3 months
* If ABPI \< 1.3, one of the following measures should be available:
* Toe Brachial Pressure Index (TBPI) \> 0.7
* Toe pressure (TP) \> 50 mmHg
* Transcutaneous oxygen pressure (TcPO2) \> 30 mmHg
* VLU duration ≥ 6 weeks
* VLU surface area:
* Isolated leg ulcer: ≤ 100 cm\^2
* Non-isolated leg ulcers: pooled surface area ≤ 100 cm\^2 that can be covered by a single dressing
* Exuding VLU according to clinical judgement
* The subject is in acceptable state of health and nutrition according to clinical judgement
* The subject is able to follow the protocol instruction and willing to comply with compression therapy
* The subject is affiliated to a French Health insurance scheme
Exclusion Criteria:
* Clinical evidence of VLU infection \[i.e. presence of at least 3 overt signs of local infection (e.g., erythema, warmth, swelling, pain, odor) or signs of spreading or systemic infection)
* Wound with necrotic tissue after debridement
* Sloughy wound (100% of slough) after debridement
* Exposed arteries, veins, nerves or organs
* Current therapy with chronic oral corticosteroids (\>10 days)
* Previous therapy with negative pressure wound therapy device or hyperbaric oxygen within 7 days prior to enrolment
* Arterial insufficiency non-revascularized
* Wound actively bleeding
* Malignant …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Venous Leg Ulcers (VLUs) confirmed healed by or at 12 weeks