Clinical Trial

PICO Negative Pressure for Uninfected Foot Ulcers and Wound Dehiscence (BALPIC)

Study acronym: BALPIC
Active, Not Recruiting
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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.
Trial Details
NCT Number NCT07398534
Lead Sponsor Ilker Uckay
Conditions Wound Dehiscence, Wound
Enrollment 300 participants
Start Date 2026-01-29
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-10