AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period

Last updated: March 19, 2024
Sponsor: ConvaTec Inc.
Overall Status: Completed

Phase

N/A

Condition

Ulcers

Venous Leg Ulcers

Diabetes And Hypertension

Treatment

Cutimed® Sorbact®

AQUACEL® Ag+ Extra™

Clinical Study ID

NCT05892341
WC-22-435
  • Ages > 18
  • All Genders

Study Summary

Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 205
Treatment Group(s): 2
Primary Treatment: Cutimed® Sorbact®
Phase:
Study Start date:
December 05, 2022
Estimated Completion Date:
February 14, 2024

Study Description

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

Connect with a study center

  • Convatec Colombia Clinic

    Barranquilla,
    Colombia

    Site Not Available

  • Convatec Colombia Clinic

    Bogotá,
    Colombia

    Site Not Available

  • Convatec Colombia Clinic

    Bucaramanga,
    Colombia

    Site Not Available

  • Convatec Colombia Clinic

    Cali,
    Colombia

    Site Not Available

  • Convatec Colombia Clinic

    Cartagena,
    Colombia

    Site Not Available

  • Convatec Colombia Clinic

    Medellín,
    Colombia

    Site Not Available

  • Convatec Germany Clinic

    Augsburg,
    Germany

    Active - Recruiting

  • Germany

    Augsburg,
    Germany

    Site Not Available

  • Convatec Germany Clinic

    Berlin,
    Germany

    Active - Recruiting

  • Germany

    Berlin,
    Germany

    Site Not Available

  • Convatec Germany Clinic

    Bochum,
    Germany

    Active - Recruiting

  • Germany

    Bochum,
    Germany

    Site Not Available

  • Convatec Germany Clinic

    Buchholz,
    Germany

    Site Not Available

  • Convatec Germany Clinic

    Düsseldorf,
    Germany

    Site Not Available

  • Germany

    Düsseldorf,
    Germany

    Site Not Available

  • Convatec Germany Clinic

    Holzkirchen,
    Germany

    Active - Recruiting

  • Germany

    Holzkirchen,
    Germany

    Site Not Available

  • Convatec Germany Clinic

    Ingolstadt,
    Germany

    Active - Recruiting

  • Germany

    Ingolstadt,
    Germany

    Site Not Available

  • Convatec Germany Clinic I

    München,
    Germany

    Active - Recruiting

  • Convatec Germany Clinic II

    München,
    Germany

    Active - Recruiting

  • Germany Clinic I

    München,
    Germany

    Site Not Available

  • Germany Clinic II

    München,
    Germany

    Site Not Available

  • Convatec Germany Clinic

    Nürnberg,
    Germany

    Active - Recruiting

  • Germany

    Nürnberg,
    Germany

    Site Not Available

  • Convatec Germany Clinic

    Ratzeburg,
    Germany

    Active - Recruiting

  • Germany

    Ratzeburg,
    Germany

    Site Not Available

  • Convatec Germany Clinic

    Rosenheim,
    Germany

    Active - Recruiting

  • Germany

    Rosenheim,
    Germany

    Site Not Available

  • Convatec Germany Clinic

    Wernigerode,
    Germany

    Site Not Available

  • Germany

    Wernigerode,
    Germany

    Site Not Available

  • Convatec Poland Clinic

    Lublin,
    Poland

    Site Not Available

  • Poland

    Lublin,
    Poland

    Site Not Available

  • Convatec UK Clinic

    Derby,
    United Kingdom

    Active - Recruiting

  • UK

    Derby,
    United Kingdom

    Site Not Available

  • VCTC UK

    Derby,
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.