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Completed

NCT Number: NCT05892341

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

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

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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Convatec Colombia Clinic, Barranquilla, Colombia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AQUACEL® Ag+ Extra™

Device

Wound treatment with AQUACEL® Ag+ Extra™ dressing

Cutimed® Sorbact®

Device

Wound treatment with Cutimed® Sorbact® dressing

Primary outcomes

  1. Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management

    Time frame: Up to 12 weeks

    Complete wound closure as defined by 100% epithelialisation of the wound surface (Gould 2019)

Secondary outcomes

  1. Wound Healing Assessment

    Time frame: Up to 4 weeks

    Percent change in study wound area

  2. Wound Progress Assessment

    Time frame: Up to 4 weeks

    Satisfactory clinical progress defined as 40% reduction in study wound area

  3. Wound Change Assessment

    Time frame: Up to 12 weeks

    Percent change in target wound area

  4. Safety Assesment

    Time frame: Up to 12 weeks

    Summary of the incidence of adverse events (AEs), device-related adverse events (ADEs) and serious device-related adverse events (SADEs)

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Collaborators

  • NAMSA

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2023
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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