ConvaVAC Ag+ NPWT for Venous Leg Ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the safety and effectiveness of the ConvaVAC Ag+ NPWT system in treating chronic venous leg ulcers. Eligible participants are adults with VLUs that are amenable to negative pressure therapy and show signs of infection. Wounds will be managed with the ConvaVAC device to assess healing outcomes and potential reductions in infection risk. The study emphasizes chronic wounds’ burden on patients and healthcare systems and aims to determine whether this therapy offers a meaningful benefit in healing time and wound quality.

Why it matters

Who can join: the full rules

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)

Where it's running

• ConvaCare Clinic
  Santiago, Santiago Metropolitan, Chile Recruiting
• Middlewood Partnership
  Bollington, Cheshire, United Kingdom Recruiting
• Knutsford Medical Partnership
  Knutsford, Cheshire, United Kingdom Recruiting
• Dorset County Hospital NHS Foundation Trust
  Dorchester, Dorset, United Kingdom Recruiting
• Assured Clinical Research Ltd
  Swaffham, Norfolk, United Kingdom Recruiting
• Northumbria Healthcare NHS Foundation Trust
  Ashington, Northumberland, United Kingdom Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Human placental membrane products plus standard care for nonhealing diabetic foot and venous leg ulcers

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• Photobiomodulation plus compression for venous leg ulcers

  This trial tests whether adding photobiomodulation to standard compression therapy helps healing venous leg ulcers.

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• Reducing skin tone inequities in chronic venous insufficiency care

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  Recruiting King's College London · London, London and 1 other locations · NCT06798766

• Evaluating Oxygen Therapy for Chronic Venous Leg Ulcers

  This study is testing if a new oxygen therapy can help heal chronic venous leg ulcers better than standard treatment in people who have these wounds.

  Recruiting Phase 4 AOTI Ltd. · New York, New York · NCT06754735

• Evaluating how long venous leg ulcers stay closed after treatment

  This study is testing how long venous leg ulcers stay closed after treatment with a special fish skin graft compared to standard care alone.

  Recruiting Kerecis Ltd. · Monroeville, Pennsylvania · NCT06697925

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.