AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
Launched by CONVATEC INC. · May 26, 2023
Trial Information
Current as of July 04, 2025
Completed
Keywords
ClinConnect Summary
Post market, multi-centre, randomised, open label, multi-national, prospective study to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- • 18 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
- Exclusion Criteria:
- • 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
About Convatec Inc.
ConvaTec Inc. is a global medical technology company dedicated to the development and commercialization of innovative products and solutions for the management of chronic and acute medical conditions. With a focus on advanced wound care, ostomy care, continence and critical care, and infusion devices, ConvaTec aims to enhance the quality of life for patients through evidence-based practices and cutting-edge research. The company is committed to clinical excellence and actively sponsors clinical trials to evaluate the safety and efficacy of its products, ensuring that they meet the highest standards of healthcare delivery and patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Berlin, , Germany
Lublin, , Poland
Barranquilla, , Colombia
Bogotá, , Colombia
Bucaramanga, , Colombia
Cali, , Colombia
Cartagena, , Colombia
Medellín, , Colombia
Berlin, , Germany
Bochum, , Germany
Buchholz, , Germany
Düsseldorf, , Germany
Ratzeburg, , Germany
Wernigerode, , Germany
Lublin, , Poland
Derby, , United Kingdom
Augsburg, , Germany
Holzkirchen, , Germany
Ingolstadt, , Germany
München, , Germany
München, , Germany
Nürnberg, , Germany
Rosenheim, , Germany
Augsburg, , Germany
Bochum, , Germany
Düsseldorf, , Germany
Holzkirchen, , Germany
Ingolstadt, , Germany
München, , Germany
München, , Germany
Nürnberg, , Germany
Ratzeburg, , Germany
Rosenheim, , Germany
Wernigerode, , Germany
Derby, , United Kingdom
Derby, , United Kingdom
Patients applied
Trial Officials
Catarina Saavedra, MD
Principal Investigator
Convatec Colombia Clinic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported