AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
A Clinical Study to Compare the Performance of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® Dressing in the Management of Patients With Venous Leg Ulcers Over a 12-week Period
1 other identifier
interventional
203
3 countries
18
Brief Summary
Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2022
CompletedFirst Submitted
Initial submission to the registry
May 10, 2023
CompletedFirst Posted
Study publicly available on registry
June 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2024
CompletedResults Posted
Study results publicly available
December 2, 2025
CompletedDecember 2, 2025
December 1, 2025
1.2 years
May 10, 2023
May 14, 2024
December 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management
Complete wound closure as defined by 100% epithelialisation of the wound surface (Gould 2019)
Up to 12 weeks
Secondary Outcomes (4)
Wound Healing Assessment
Up to 4 weeks
Wound Progress Assessment
Up to 4 weeks
Wound Change Assessment
Up to 12 weeks
Safety Assesment
Up to 12 weeks
Study Arms (2)
AQUACEL® Ag+ Extra™
ACTIVE COMPARATORAQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing
Cutimed® Sorbact®
ACTIVE COMPARATORCutimed® Sorbact® is approved, bacterial and fungi binding wound dressing
Interventions
Eligibility Criteria
You may qualify if:
- Venous insufficiency as defined by CEAP Classification of C6
- One wound amendable to treatment with either AQUACEL® Ag+ Extra™ or Cutimed® Sorbact®
- Wounds that have been present for at least 2 months
- Reliable and available for follow-up
- years or older
- Able and willing to provide informed consent
- Able to tolerate compression therapy for Venus Leg Ulcer
- Must be able to be compliant with compression therapy
You may not qualify if:
- Known sensitivities or allergies to components of the AQUACEL® Ag+ Extra™ or Cutimed® Sorbact®
- Continued use of petroleum gel/ creams/ oil-based products
- Active treatment for cancer or completed within the last 3 months
- Documented severe malnutrition
- Malignant wounds
- Systemic infection actively treated with antibiotics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ConvaTec Inc.lead
- NAMSAcollaborator
Study Sites (18)
Convatec Colombia Clinic
Barranquilla, Colombia
Convatec Colombia Clinic
Bogotá, Colombia
Convatec Colombia Clinic
Bucaramanga, Colombia
Convatec Colombia Clinic
Cali, Colombia
Convatec Colombia Clinic
Cartagena, Colombia
Convatec Colombia Clinic
Medellín, Colombia
Germany
Augsburg, Germany
Germany
Berlin, Germany
Germany
Bochum, Germany
Germany
Düsseldorf, Germany
Germany
Holzkirchen, Germany
Germany
Ingolstadt, Germany
Germany Clinic II
München, Germany
Germany Clinic I
München, Germany
Germany
Nuremberg, Germany
Germany
Ratzeburg, Germany
Germany
Rosenheim, Germany
VCTC UK
Derby, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cristin Taylor, Senior Director, Medical Affairs, Advanced Wound Care
- Organization
- ConvaTec Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Catarina Saavedra, MD
Convatec Colombia Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2023
First Posted
June 7, 2023
Study Start
December 5, 2022
Primary Completion
February 14, 2024
Study Completion
February 14, 2024
Last Updated
December 2, 2025
Results First Posted
December 2, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share