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

Not Applicable

Completed

• Conditions: Venous Leg Ulcer; Diabetic Foot
• Interventions: Device: AQUACEL® Ag+ Extra™; Device: Cutimed® Sorbact®

• Registration Number: NCT05892341
• Lead Sponsor: ConvaTec Inc.

Brief Summary

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

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 Timeline

• Study Start: 2022-12-05
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-06-07
• Primary Completion: 2024-02-14
• Study Completion: 2024-02-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AQUACEL® Ag+ Extra™	AQUACEL® Ag+ Extra™	AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing
Cutimed® Sorbact®	Cutimed® Sorbact®	Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing

Primary Outcome Measures

Name	Time	Method
Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on wound management	Up to 12 weeks	Complete wound closure as defined by 100% epithelialisation of the wound surface (Gould 2019)

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Germany; 🇩🇪 Rosenheim, Germany

Convatec Colombia Clinic; 🇨🇴 Medellín, Colombia

Germany Clinic I; 🇩🇪 München, Germany

VCTC UK; 🇬🇧 Derby, United Kingdom

Germany Clinic II; 🇩🇪 München, Germany