AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
NCT ID: NCT05892341
Last Updated: 2025-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
203 participants
INTERVENTIONAL
2022-12-05
2024-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AQUACEL® Ag+ Extra™
AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing
AQUACEL® Ag+ Extra™
Wound treatment with AQUACEL® Ag+ Extra™ dressing
Cutimed® Sorbact®
Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing
Cutimed® Sorbact®
Wound treatment with Cutimed® Sorbact® dressing
Interventions
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AQUACEL® Ag+ Extra™
Wound treatment with AQUACEL® Ag+ Extra™ dressing
Cutimed® Sorbact®
Wound treatment with Cutimed® Sorbact® dressing
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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NAMSA
OTHER
ConvaTec Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Catarina Saavedra, MD
Role: PRINCIPAL_INVESTIGATOR
Convatec Colombia Clinic
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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WC-22-435
Identifier Type: -
Identifier Source: org_study_id
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