Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:51 AM
Study NCT ID:
NCT07398534
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PICO Negative Pressure for Uninfected Foot Ulcers and Wound Dehiscence (BALPIC)
Sponsor:
Ilker Uckay
Organization:
Study Overview
Official Title:
PICO Negative Pressure for the Treatment of Uninfected Foot Ulcers and Wound Dehiscence - an Unblinded, Randomized-controlled, Superiority Trial (BALPIC Trial)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BALPIC
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.
Detailed Description:
Acute postoperative wound dehiscence and foot ulcers represent a frequent clinical challenge in adult orthopedic patients worldwide. According to institutional data, wound dehiscence occurs in 2-5% of elective orthopedic procedures, depending on surgery type, patient comorbidities, and obesity. Among patients with diabetes, approximately half will develop foot ulcers during their lifetime.
The management of non-infected wounds can be either surgical (revision surgery with primary closure) or conservative (professional debridement and wound care with or without negative pressure wound therapy). Despite widespread clinical experience with NPWT in orthopedic surgery, high-quality prospective evidence remains scarce. The orthopedic literature lacks adequately powered randomized controlled trials comparing NPWT to standard wound care for acute, non-infected wound dehiscence.
The investigators hypothesize that NPWT leads to superior wound closure rates (85% vs. 70%) and accelerated healing compared to professional debridement alone. The PICO Single Use Negative Pressure Wound Therapy System creates a closed environment over the wound, evacuating exudate into an absorptive dressing while promoting secondary closure through controlled suction at -80 mmHg.
The BALPIC trial evaluates a therapeutic concept rather than comparing different NPWT devices. Infected wounds are excluded, as NPWT is conventionally avoided over purulent wounds to allow free drainage. Wound assessment is performed by specialized wound nurses using standardized measurements and photographic documentation.
The management of non-infected wounds can be either surgical (revision surgery with primary closure) or conservative (professional debridement and wound care with or without negative pressure wound therapy). Despite widespread clinical experience with NPWT in orthopedic surgery, high-quality prospective evidence remains scarce. The orthopedic literature lacks adequately powered randomized controlled trials comparing NPWT to standard wound care for acute, non-infected wound dehiscence.
The investigators hypothesize that NPWT leads to superior wound closure rates (85% vs. 70%) and accelerated healing compared to professional debridement alone. The PICO Single Use Negative Pressure Wound Therapy System creates a closed environment over the wound, evacuating exudate into an absorptive dressing while promoting secondary closure through controlled suction at -80 mmHg.
The BALPIC trial evaluates a therapeutic concept rather than comparing different NPWT devices. Infected wounds are excluded, as NPWT is conventionally avoided over purulent wounds to allow free drainage. Wound assessment is performed by specialized wound nurses using standardized measurements and photographic documentation.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: