Smith & Nephew’s PICO Venous Leg Ulcer Study Terminated: What Investors Should Know

Smith & Nephew Snats (SNN) announced an update on their ongoing clinical study.

Study Overview
This study, officially titled “A Pragmatic, Multi-centre, Prospective, Randomized, Superiority Study to Compare the Performance of the Single-use Negative Pressure Wound Therapy System PICO Versus Standard of Care in the Management of Venous Leg Ulcers,” was designed to test whether Smith & Nephew’s PICO device can outperform standard dressings for hard-to-heal venous leg ulcers treated in the community. The goal was to show a higher rate of healed ulcers within 12 weeks, a result that would support broader use and reimbursement in a large, chronic wound market.

Intervention/Treatment
The trial compared two approaches. The first used the PICO 7 system, a small, single-use negative pressure wound therapy device applied on top of compression therapy. The second used standard wound dressings and compression, adjusted as the wound progressed. Both arms aimed to heal the ulcer, but PICO adds a device-based suction therapy intended to speed up healing and improve outcomes.

Study Design
This was an interventional, randomized study with two parallel groups: one receiving PICO plus standard care and one receiving standard care alone. Patients were randomly assigned to each arm. Outcome assessors were blinded by reviewing wound photos without knowing which treatment was used. The main purpose was treatment-focused: to see which method produced more healed ulcers within 12 weeks.

Study Timeline
The study was first submitted on July 15, 2024, marking the formal start of regulatory tracking and signaling early-stage execution. The latest update was submitted on January 6, 2026, showing that the sponsor has recently refreshed the record. The trial status is now listed as terminated, which means it stopped early and will not reach its originally planned completion; no primary or final completion dates are posted, so investors should view the program as effectively halted pending any future redesign or follow-up work.

Market Implications
For Smith & Nephew (SNN), a terminated venous leg ulcer reimbursement study removes a potential near-term catalyst for expanding PICO’s reimbursed indications and usage. While PICO remains a commercial product, the loss of this specific evidence pathway may delay or limit incremental growth in the chronic wound segment and could weigh slightly on investor expectations around upside from advanced wound therapies. Competitors in negative pressure wound therapy and advanced dressings, including larger diversified medtech players, may face less immediate pressure from fresh comparative data. However, the broader wound care market remains structurally attractive, and investors will likely focus on whether SNN reallocates R&D and commercial resources into other evidence programs or adjacent indications to support long-term growth. The recent update confirms that the study is no longer ongoing, and further details are available on the ClinicalTrials portal.