PICO Venous Leg Ulcers (VLU) Reimbursement Study
← catalyst calendarSponsored by Smith & Nephew, Inc. (industry) · SNN — their whole pipeline →. With CEN Biotech, T.J. Smith and Nephew, Limited.
Phase
Not applicable
Status
Terminated
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
142actual
Sites
44
Country
France
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Early terminated due to protocol design issues with inability to correct at this stage.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-12-29 | actual | When the study began enrolling |
| Primary completion | 2025-10-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-24 | actual | The whole study's end, after follow-up |
| First posted | 2024-07-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Venous Insufficiency
- Venous Leg Ulcer
Interventions
- Device: PICO Treatment — also filed as Single-Use Negative Pressure Therapy System PICO 7 (sNPWT)
- Device: Standard of Care (SOC) Treatment — also filed as Traditional wound dressings in addition to compression therapy.
Primary outcome
what the primary-completion date above is the date OFNumber of Venous Leg Ulcers (VLUs) confirmed healed by or at 12 weeks
measured Up to 12 weeks
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