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

NCT07398534 | Active Not Recruiting DMC

• 1 other identifier: BASEC 2025-D0043
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Dehiscence; Wound

Keywords

acute wound; negative pressure vacuum therapy; prospective-randomized trial

Outcome Measures

Primary Outcomes (1)

• Wound closure without surgical revision at Day 42

  Wound closure is defined as reduction of wound size by a minimum of 90% compared to baseline, without need for surgical revision. Wound failure is defined as persistent wound (less than 90% reduction) after 42 days or surgical wound revision during the study period.

  Day 42 (±7 days)

Secondary Outcomes (6)

• 2. Rapidity of wound closure

  Day 7, 14, 21, 28, 35, and 42

• Wound closure without surgical revision at Day 7, 14, 21, 28, and 35

  Day 7, 14, 21, 28, and 35 (±2 days)

• 4. Wound closure for diabetic foot ulcers only (stratified analysis)

  Day 42 (±7 days)

• 5. Adverse events related to wound therapy

  Day 1 to Day 42 (±7 days)

• 6. Length of hospital stay

  Day 1 to Day 42 (±7 days)

Study Arms (2)

PICO

EXPERIMENTAL

Application of PICO 7 Single Use NPWT System at -80 mmHg for a minimum of 7 days. PICO therapy may be continued for up to 42 days based on clinical necessity. Device change every 7 days. Wound assessment weekly. SMITH \& NEPHEW MEDICAL LTD. PICO 7 15CM X 20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP (UDI 04582111156419). The PICO system creates a closed environment over the wound, evacuating exudate into an absorptive dressing while promoting wound closure through controlled suction.

Procedure: Professional Wound Care

Professional Wound CAre

OTHER

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.

Procedure: Professional Wound Care

Interventions

Professional Wound Care PROCEDURE

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.

PICO; Professional Wound CAre

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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
• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Ilker Uckay: lead

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Ilker Uçkay, Prof. Dr. med.

  Balgrist University Hospital, University of Zurich, Zurich, Swizerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Ilker Uçkay

Model Details: Unblinded, prospective-randomized superiority trial in favor of PICO use

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 10, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After the final analysis
• Access Criteria: Reasonable scientific request to the corresponding Sponsor-Investigator

Locations

CH (1)