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

NCT07342049 | Recruiting

• 2 other identifiers: WC-24-452359501
• Study Type: interventional
• Target: 87
• Locations: 2 countries
• Sites: 7

Brief Summary

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.

Conditions

Venous Leg Ulcer (VLU)

Keywords

Venous Leg Ulcer; Negative Pressure Wound Therapy; Silver ions

Outcome Measures

Primary Outcomes (1)

• Percentage area reduction (PAR) in wound size at day 14

  Difference between wound area at day 0 and day 14 of treatment

  14 days

Study Arms (1)

ConvaVAC Ag+

EXPERIMENTAL

Negative Pressure Wound Therapy system

Device: ConvaVAC™ Ag+ Negative Pressure Wound Therapy System

Interventions

ConvaVAC™ Ag+ Negative Pressure Wound Therapy System DEVICE

ConvaVAC™ Ag+ Negative Pressure Wound Therapy System

ConvaVAC Ag+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (7)

ConvaCare Clinic

Santiago, Santiago Metropolitan, Chile

RECRUITING

Middlewood Partnership

Bollington, Cheshire, SK10 5JH, United Kingdom

RECRUITING

Knutsford Medical Partnership

Knutsford, Cheshire, WA16 9DX, United Kingdom

RECRUITING

Dorset County Hospital NHS Foundation Trust

Dorchester, Dorset, DT1 2JY, United Kingdom

RECRUITING

Assured Clinical Research Ltd

Swaffham, Norfolk, PE37 7RD, United Kingdom

RECRUITING

Northumbria Healthcare NHS Foundation Trust

Ashington, Northumberland, NE630HP, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

CL (1); GB (6)