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PICO Negative Pressure for Uninfected Foot Ulcers and Wound Dehiscence (BALPIC)
Sponsor: Ilker Uckay
Summary
The investigators compare negative pressure wound therapy (NPWT) using the PICO 7 system versus professional wound debridement alone in adult orthopedic patients with acute, non-infected wound dehiscence or diabetic foot ulcers. Patients are randomized 1:1 to either PICO therapy (minimum 7 days, up to 42 days) or standard wound care (professional debridement without NPWT). The primary outcome is wound closure without surgical revision at Day 42. The trial is stratified for diabetic foot ulcers to enable subgroup analysis.
Official title: PICO Negative Pressure for the Treatment of Uninfected Foot Ulcers and Wound Dehiscence - an Unblinded, Randomized-controlled, Superiority Trial (BALPIC Trial)
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-01-29
Completion Date
2028-06-30
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
Professional Wound Care
Professional wound debridement by specialized wound nurses, including dressing changes and local antiseptics if clinically indicated, without the use of any negative pressure device. Treatment for up to 42 days based on clinical necessity. Wound assessment weekly. Individualized professional wound care according to hospital and Swiss nursing guidelines. The intensity of debridement, dressing type, and antiseptic use lies at the discretion of the wound nurse and will be recorded.
Locations (1)
Balgrist University Hospital
Zurich, Switzerland