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

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

Detailed Description
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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

Official Title
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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

Conditions
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Venous Leg Ulcer, Diabetic Foot

Intervention / Treatment
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* Device: AQUACEL® Ag+ Extra™
* Device: Cutimed® Sorbact®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |