Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds. In this study, the focus is on Venous Leg Ulcers (VLUs). Chronic wounds are wounds that do not heal properly or take a long time to heal. They can cause pain, discomfort, and affect your day-to-day life. These types of wounds are also challenging for healthcare teams to treat and can take up a lot of healthcare resources. Venous Leg Ulcers (VLUs) are the most common type of chronic leg wound and affect about 1 in every 100 people. Usual treatments for VLUs include cleaning the wound, using special dressings, applying pressure (compression therapy), and sometimes using creams or dressings that contain silver to fight infection. This study is being done to see if the wound therapy system can help heal venous leg ulcers more effectively and safely.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Percentage area reduction (PAR) in wound size at day 14 — 14 days Difference between wound area at day 0 and day 14 of treatment
Trial sites (7)
Facility
City
Region
Status
ConvaCare Clinic
Santiago
Santiago Metropolitan
Recruiting
Middlewood Partnership
Bollington
Cheshire
Recruiting
Knutsford Medical Partnership
Knutsford
Cheshire
Recruiting
Dorset County Hospital NHS Foundation Trust
Dorchester
Dorset
Recruiting
Assured Clinical Research Ltd
Swaffham
Norfolk
Recruiting
Northumbria Healthcare NHS Foundation Trust
Ashington
Northumberland
Recruiting
Nottingham University Hospitals NHS Trust
Nottingham
Nottinghamshire
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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