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New device aims to heal stubborn leg wounds faster

NCT ID NCT07342049

Symptom relief Sponsor: ConvaTec Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 2 times

Summary

This study tests a new wound therapy system called ConvaVAC™ Ag+ in 87 people with chronic venous leg ulcers. The device uses negative pressure and silver to clean and help heal wounds that won't close on their own. Researchers will check if it safely reduces wound size after 14 days of treatment.

What this could mean

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

Active substance
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System (a device that uses negative pressure and silver to treat wounds)
What this could lead to
If it works, this could offer a more effective way to heal chronic leg ulcers, reducing pain and improving quality of life.
What could go wrong
This is an early-stage study with only 87 people, so results may not apply to everyone. The device may not heal wounds faster than standard care, and some people may have allergies to its components.

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 87 people

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

Started

Jan 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: * A wound which is amenable to NPWT and is a VLU as defined by CEAP Classification of C6 or C6R * Wounds that are clean or contaminated * Wounds with at least one sign or symptom of infection * Wounds that in the opinion of the investigator would benefit from an antimicrobial dressing * ≥18 years old at the time of consent Exclusion Criteria: * Known sensitivities or allergies to components of the ConvaVAC™ Ag+ NPWT System * Ischemic wounds with necrotic tissue or eschar present that require sharp debridement * Wound is too small or too large based on wound dressing size (\> 0.5cm2 and \< 100cm2) * Wound depth \>7cm * Wounds requiring concomitant use of DuoDERM® gel, hydrogels, petroleum-based creams/ ointment-/gels per the opinion of the investigator * Active chemotherapy, radiation therapy, or immunotherapy for cancer or completed treatment within the last 3 months * Any active malignancy at site of dressing application * Exposed bone in target wound * Exposed blood vessels or nerves in target wound * Systemic infection and/or systemic inflammatory response syndrome (SIRS), sepsis * Cellulitis in target wound * Untreated deep tissue infection including but not limited to osteomyelitis, septic arthritis * Active Pregnancy * Subjects that in the opinion of the investigator are not suitable for enrollment * Vulnerable subjects as determined by ICH Harmonized Guideline, Good Clinical Practice E6(R2)

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Conditions

The condition(s) this trial relates to.

ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

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

Venous leg ulcer (VLU)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Assured Clinical Research Ltd

    RECRUITING

    Swaffham, Norfolk, PE37 7RD, United Kingdom

  • ConvaCare Clinic

    RECRUITING

    Santiago, Santiago Metropolitan, Chile

  • Dorset County Hospital NHS Foundation Trust

    RECRUITING

    Dorchester, Dorset, DT1 2JY, United Kingdom

  • Knutsford Medical Partnership

    RECRUITING

    Knutsford, Cheshire, WA16 9DX, United Kingdom

  • Middlewood Partnership

    RECRUITING

    Bollington, Cheshire, SK10 5JH, United Kingdom

  • Northumbria Healthcare NHS Foundation Trust

    RECRUITING

    Ashington, Northumberland, NE630HP, United Kingdom

  • Nottingham University Hospitals NHS Trust

    RECRUITING

    Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

More trials for these conditions

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