What is the ConvaVAC13 Ag+ system studying for venous leg ulcers?

The ConvaVAC13 Ag+ system is being studied to learn how safe and effective it is in treating venous leg ulcers, a common type of chronic wound. Researchers want to see if this negative pressure wound therapy device combined with silver ions can improve healing outcomes and reduce infection risks. The study is sponsored by ConvaTec Inc.

Who may be eligible for this venous leg ulcer clinical trial?

Adults aged 18 years or older with venous leg ulcers suitable for negative pressure wound therapy may be eligible. The study includes wounds that are clean or contaminated and show signs of infection. People who are pregnant or have allergies to the device components cannot join. Please review eligibility criteria for more details.

Is there any cost to participate in this venous leg ulcer clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. Personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07342049

Study to Evaluate the Safety and Effectiveness of ConvaVAC17 Ag Negative Pressure Wound Therapy System for Treating Venous Leg Ulcers

Led by ConvaTec Inc. · Updated on 2026-07-09

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and performance of the ConvaVAC13 Ag Negative Pressure Wound Therapy System in treating chronic wounds, specifically focusing on Venous Leg Ulcers VLUs. Chronic wounds are those that heal slowly or not at all, causing pain and affecting daily life. VLUs are the most common chronic leg wounds, affecting about 1 in 100 people, and current treatments include wound cleaning, special dressings, compression therapy, and antimicrobial creams or dressings. This study aims to see if the ConvaVAC13 Ag system can improve healing outcomes for VLUs effectively and safely. The ConvaVAC13 Ag system is a device that uses negative pressure wound therapy NPWT combined with silver ions, which have antimicrobial properties. NPWT involves applying a sealed dressing connected to a vacuum pump that removes excess fluid, promotes tissue growth, and reduces bacteria in the wound. The study involves participants receiving treatment with this device on their VLUs. The system aims to support wound healing by removing harmful biofilms and promoting tissue repair. Participants will be involved in the study for at least 14 days, during which the main measurement is the percentage reduction in wound size at day 14. Researchers will monitor wound healing progress and safety throughout the treatment period. The study helps assess how well the device performs in managing VLUs, with evaluations of wound condition and patient outcomes. The total participation time may vary depending on individual wound response and healing progress.

CONDITIONS

Brief Title

ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

A wound suitable for negative pressure wound therapy classified as a venous leg ulcer (CEAP Classification C6 or C6R)
Wounds that are clean or contaminated
Wounds showing at least one sign or symptom of infection
Wounds that are judged to benefit from an antimicrobial dressing
Age 18 years or older at the time of consent

You will not qualify if you...

Known allergies or sensitivities to components of the ConvaVAC13 Ag+ system
Ischemic wounds with necrotic tissue or eschar needing sharp debridement
Wounds smaller than 0.5 cm2 or larger than 100 cm2
Wound depth greater than 7 cm
Use of certain wound treatments such as DuoDERM�ae gel, hydrogels, or petroleum-based creams as judged unsuitable
Active cancer treatment or completed within the last 3 months
Active malignancy at the wound site
Exposed bone, blood vessels, or nerves in the wound
Systemic infection, sepsis, or systemic inflammatory response syndrome
Cellulitis or untreated deep tissue infections like osteomyelitis or septic arthritis
Pregnancy
Subjects deemed unsuitable by the investigator
Vulnerable subjects as defined by Good Clinical Practice guidelines

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