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New treatment option for Venous Leg Ulcer (VLU)
Official title ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
ClinicalTrials.gov ID: NCT07342049
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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
- people that in the opinion of the investigator are not suitable for enrollment
- Vulnerable people as determined by ICH Harmonized Guideline, Good Clinical Practice E6(R2)
The study team makes the final eligibility decision.
Where it's taking place
- Santiago, Santiago Metropolitan, Chile
- Bollington, Cheshire, United Kingdom
- Knutsford, Cheshire, United Kingdom
- Dorchester, Dorset, United Kingdom
- Swaffham, Norfolk, United Kingdom
- Ashington, Northumberland, United Kingdom
- Nottingham, Nottinghamshire, United Kingdom
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santiago, Santiago Metropolitan, Chile; Bollington, Cheshire, United Kingdom; Knutsford, Cheshire, United Kingdom; Dorchester, Dorset, United Kingdom; Swaffham, Norfolk, United Kingdom; Ashington, Northumberland, United Kingdom and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.