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Can a vacuum bandage heal foot wounds faster?

NCT ID NCT07398534

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a special suction bandage (PICO) to standard wound cleaning for foot ulcers and wounds that have reopened after surgery. 300 adults with non-infected wounds are randomly assigned to either the suction device or usual care. The main goal is to see if the suction bandage leads to wound closure within 42 days without needing another surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PICO 7 negative pressure wound therapy system
What this could lead to
If it works, this could provide a faster, non-surgical way to close foot ulcers and surgical wounds, reducing the need for additional operations.
What could go wrong
This is a single-center trial with no blinding, so results may be less reliable. The therapy may not speed healing enough to justify its cost and inconvenience.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Balgrist University Hospital

    Zurich, 8008, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.