PICO Negative Pressure for Uninfected Foot Ulcers and Wound Dehiscence (BALPIC) (NCT07398534) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PICO Negative Pressure for Uninfected Foot Ulcers and Wound Dehiscence (BALPIC)
Switzerland300 participantsStarted 2026-01-29
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- Age ≥ 18 years
* Able to consent
* Patient of orthopaedic surgery or of the (Diabetic) Foot Polyclinic at the Balgrist University Hospital
* Presence of an acute, dehiscent, clinically uninfected wound requiring additional measures
* First episode of wound treatment for the actual wound (no recurrences) in the last 12 months
* Wound measuring ≥ 0.5 cm in wide, length or depth
* 42 days of scheduled follow-up
* Bacterial orthopaedic infections of any nature, independently of implants or co-morbidities; according to clinical, laboratory, radiological, microbiological features of infection
* First or second episode of infection
Exclusion Criteria:
* \- Patient's individual refusal to participate
* Patient already treated with any vacuum-assisted wound device for any wound in the last 12 months; independently of therapy success, the hospital or the localization of the prior wound
* Underlying liquor leak (spine surgery)
* Visually active bleeding from the wound
* Wound size \>10 cm in any dimension
* Anticipated active clinical follow-up of less than 42 days
* Other wound treatments besides PICO and debridement (e.g. hyperbaric oxygen therapy, other negative-pressure devices, local antibiotics, local antibiotic dressings) (however, local antiseptics and dressing changes remain allowed)
* Immediate surgical wound revision in the operating theatre for closure
* Planned plastic or reconstructive surgery already at inclusion