Venous Leg UlcerNCT05892341

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

A study testing AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® in people with Venous Leg Ulcer and Diabetic Foot, run by ConvaTec Inc. at 18 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Venous Leg Ulcer, Diabetic Foot
What is being tested?: AQUACEL® Ag+ Extra™ and Cutimed® Sorbact®
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 203 participants
Where: 18 sitesin 3 countries
Study dates: 5 Dec 2022to 14 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

18 sites in 3 countries.

Country

City, postcode or hospital

18 sites in 3 countries

Germany11 sites

Germany
Augsburg
Germany
Berlin
Germany
Bochum
Germany
Düsseldorf
Germany
Holzkirchen
Germany
Ingolstadt
Germany Clinic II
München
Germany Clinic I
München
Germany
Nuremberg
Germany
Ratzeburg
Germany
Rosenheim

Other trials in Germany

Colombia6 sites

Convatec Colombia Clinic
Barranquilla
Convatec Colombia Clinic
Bogotá
Convatec Colombia Clinic
Bucaramanga
Convatec Colombia Clinic
Cali
Convatec Colombia Clinic
Cartagena
Convatec Colombia Clinic
Medellín

Other trials in Colombia

United Kingdom1 site

VCTC UK
Derby

Other trials in United Kingdom

About this study

Official 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

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

Read the 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

Conditions: Venous Leg Ulcer, Diabetic Foot
Being tested: AQUACEL® Ag+ Extra™, Cutimed® Sorbact®
Medical subject headings: Varicose Ulcer, Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AQUACEL® Ag+ Extra™Device
Wound treatment with AQUACEL® Ag+ Extra™ dressing
Cutimed® Sorbact®Device
Wound treatment with Cutimed® Sorbact® dressing

Study groups in NCT05892341
Study group	Role	What they receive
AQUACEL® Ag+ Extra™	Active comparator	AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing Receives: Device: AQUACEL® Ag+ Extra™
Cutimed® Sorbact®	Active comparator	Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing Receives: Device: Cutimed® Sorbact®

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Up to 12 weeks

Secondary outcomes (4)

Wound Healing Assessment
Percent change in study wound area
Measured: Up to 4 weeks
Wound Progress Assessment
Satisfactory clinical progress defined as 40% reduction in study wound area
Measured: Up to 4 weeks
Wound Change Assessment
Percent change in target wound area
Measured: Up to 12 weeks
Safety Assesment
Summary of the incidence of adverse events (AEs), device-related adverse events (ADEs) and serious device-related adverse events (SADEs)
Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 202214 Feb 2024

First posted7 Jun 2023
Study start5 Dec 2022
Primary completion14 Feb 2024
Study completion14 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05892341
Sponsor's protocol ID: WC-22-435
Status last verified: Dec 2025
First submitted: 10 May 2023
Last updated: 2 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Venous Leg Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT05892341
Acronym / sponsor ID: WC-22-435
Conditions: Venous Leg Ulcer, Diabetic Foot
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: ConvaTec Inc.Industry (pharma, biotech, devices)
Collaborators: NAMSA
Study start: 5 Dec 2022 (actual)
Primary completion: 14 Feb 2024 (actual)
Study completion: 14 Feb 2024 (actual)
First posted: 7 Jun 2023 (actual)
Results: Posted 2 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
AQUACEL® Ag+ Extra™	Active comparator	Device: AQUACEL® Ag+ Extra™AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing
Cutimed® Sorbact®	Active comparator	Device: Cutimed® Sorbact®Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AQUACEL® Ag+ Extra™Wound treatment with AQUACEL® Ag+ Extra™ dressing	Device	AQUACEL® Ag+ Extra™
Cutimed® Sorbact®Wound treatment with Cutimed® Sorbact® dressing	Device	Cutimed® Sorbact®

Primary outcome

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)

4 secondary outcomes

Wound Healing Assessment
Time frame: Up to 4 weeks
Wound Progress Assessment
Time frame: Up to 4 weeks
Wound Change Assessment
Time frame: Up to 12 weeks
Safety Assesment
Time frame: Up to 12 weeks

Results and safety

Results posted to the registry on 2 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AQUACEL® Ag+ Extra™	101	88
Cutimed® Sorbact®	102	79

Primary outcome: Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management

Time frame: Up to 12 weeks. Count of units. Unit: Number of Wounds

Measure	AQUACEL® Ag+ Extra™ n = 101	Cutimed® Sorbact® n = 102
Value	80	60

Population analysed: Proportion of study wounds with complete wound healing by Week 12

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AQUACEL® Ag+ Extra™	3 of 101 (3%)	8 of 101 (7.9%)	0 of 101
Cutimed® Sorbact®	6 of 102 (5.9%)	21 of 102 (20.6%)	1 of 102

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
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Recruiting
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RecruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Catarina Saavedra, MD principal investigator

Convatec Colombia Clinic

18 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® in people with Venous Leg Ulcer and Diabetic Foot, run by ConvaTec Inc. at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany, Colombia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05892341.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.