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

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

Study Overview

• Status: Completed
• Conditions: Diabetic Foot; Venous Leg Ulcer
• Intervention / Treatment: Device: AQUACEL® Ag+ Extra™; Device: Cutimed® Sorbact®

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catarina Saavedra, MD; Phone Number: 3173637942; Email: info@clinicasesteticas.com.co
• Study Contact Backup: Name: Markus Stuecker, MD; Email: info@klinikum-bochum.de

Study Locations

• Colombia
  • 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
    • Convatec Colombia Clinic
• Germany
  • Augsburg, Germany
    • Germany
  • Berlin, Germany
    • Germany
  • Bochum, Germany
    • Germany
  • Düsseldorf, Germany
    • Germany
  • Holzkirchen, Germany
    • Germany
  • Ingolstadt, Germany
    • Germany
  • München, Germany
    • Germany Clinic II
  • München, Germany
    • Germany Clinic I
  • Nürnberg, Germany
    • Germany
  • Ratzeburg, Germany
    • Germany
  • Rosenheim, Germany
    • Germany
• United Kingdom
  • Derby, United Kingdom
    • VCTC UK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AQUACEL® Ag+ Extra™; AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing	Device: AQUACEL® Ag+ Extra™; Wound treatment with AQUACEL® Ag+ Extra™ dressing
Active Comparator: Cutimed® Sorbact®; Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing	Device: Cutimed® Sorbact®; Wound treatment with Cutimed® Sorbact® dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing assessment	Percent change in study wound area	Up to 4 weeks
Wound progress assessment	Satisfactory clinical progress defined as 40% reduction in study wound area	Up to 4 weeks
Wound change assessment	Percent change in target wound area	Up to 12 weeks
Safety assesment	Summary of the incidence of adverse events (AEs), device-related AEs and serious device-related AEs	Up to 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	Numeric Rating Scale from 0 to 10	Up to 12 weeks
Quality of Life assesment	Wound-QoL-14 global score	Up to 12 weeks

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Collaborators: NAMSA
• Investigators: Principal Investigator: Catarina Saavedra, MD, Convatec Colombia Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Actual): February 14, 2024
• Study Completion (Actual): February 14, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Varicose Veins; Foot Ulcer; Diabetic Foot; Ulcer; Leg Ulcer; Varicose Ulcer; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: WC-22-435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No