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CompletedNCT05892341Updated Dec 2, 2025Results posted

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

An interventional study of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® in Venous Leg Ulcer and Diabetic Foot, sponsored by ConvaTec Inc.. Completed at 18 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by ConvaTec Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Dec 2022, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
203
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Venous Leg Ulcer
  • Diabetic Foot
03

In context

Varicose Ulcer

378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.

This study's enrollment of 203 is above the median of 64 across 325 interventional studies indexed under Varicose Ulcer.

Browse Varicose Ulcer studies →

Lead sponsor

ConvaTec Inc. is the lead sponsor of 43 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
203 participants (actual)

Study arms

  • Active comparator
    AQUACEL® Ag+ Extra™

    AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing

    Device: AQUACEL® Ag+ Extra™

  • Active comparator
    Cutimed® Sorbact®

    Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing

    Device: Cutimed® Sorbact®

Interventions

  • DeviceAQUACEL® Ag+ Extra™

    Wound treatment with AQUACEL® Ag+ Extra™ dressing

  • DeviceCutimed® Sorbact®

    Wound treatment with Cutimed® Sorbact® dressing

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Wound Healing Assessment

    Percent change in study wound area

    Time frame: Up to 4 weeks

  2. Wound Progress Assessment

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

    Time frame: Up to 4 weeks

  3. Wound Change Assessment

    Percent change in target wound area

    Time frame: Up to 12 weeks

  4. Safety Assesment

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

    Time frame: Up to 12 weeks

07

Results

Posted Dec 2, 2025

Participant flow

Participant flow — Overall Study
MilestoneAQUACEL® Ag+ Extra™Cutimed® Sorbact®
Started101102
Completed8879
Not completed1323

Outcome measures

PrimaryEffectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management

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

Time frame:
Up to 12 weeks
Reported as:
Count of units · Number of Wounds
Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management
Number of WoundsAQUACEL® Ag+ Extra™Cutimed® Sorbact®
Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management8060
SecondaryWound Healing Assessment

Percent change in study wound area

Time frame:
Up to 4 weeks
Reported as:
Mean · Percent change in wound size
Wound Healing Assessment
Percent change in wound sizeAQUACEL® Ag+ Extra™Cutimed® Sorbact®
Wound Healing Assessment-62.66 ± 43.54-48.31 ± 49.97
SecondaryWound Progress Assessment

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

Time frame:
Up to 4 weeks
Reported as:
Number · Number of Wounds
Wound Progress Assessment
Number of WoundsAQUACEL® Ag+ Extra™Cutimed® Sorbact®
Wound Progress Assessment81 (69.11 to 85.17)70 (55.81 to 73.82)
SecondaryWound Change Assessment

Percent change in target wound area

Time frame:
Up to 12 weeks
Reported as:
Mean · Percent change in wound size
Wound Change Assessment
Percent change in wound sizeAQUACEL® Ag+ Extra™Cutimed® Sorbact®
Wound Change Assessment-90.33 ± 27.09-67.22 ± 55.13
SecondarySafety Assesment

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

Time frame:
Up to 12 weeks
Reported as:
Number · participants
Safety Assesment
participantsAQUACEL® Ag+ Extra™Cutimed® Sorbact®
Any AE, subjects1127
Any SAE, subjects36
Adverse Device Effects14
Serious Adverse Device Effect01

Adverse events

Collected over 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).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AQUACEL® Ag+ Extra™0/101 (0%)3/101 (3%)8/101 (7.9%)
Cutimed® Sorbact®1/102 (1%)6/102 (5.9%)21/102 (20.6%)
Most frequent serious events
Most frequent serious events
EventAQUACEL® Ag+ Extra™Cutimed® Sorbact®
Ischaemic heart diseaseCardiac disorders1/1010/102
Chest infectionInfections and infestations1/1010/102
UTIInfections and infestations1/1011/102
Gastrointestinal bleedingGastrointestinal disorders0/1011/102
DeathGeneral disorders0/1011/102
Allergic reaction to drugImmune system disorders0/1011/102
Cellulitis on left lower legInfections and infestations0/1011/102
Unspecified local infection of skin and subcutaneous tissueInfections and infestations0/1011/102
Most frequent other events
Showing 10 of 21
Most frequent other events
EventAQUACEL® Ag+ Extra™Cutimed® Sorbact®
Wound infectionInfections and infestations3/1014/102
InfectionInfections and infestations0/1012/102
Wound painInjury, poisoning and procedural complications0/1012/102
UTIInfections and infestations1/1010/102
Ulcer bleedingGeneral disorders1/1010/102
FallInjury, poisoning and procedural complications1/1010/102
OvergranulationSkin and subcutaneous tissue disorders1/1010/102
UlcerGeneral disorders1/1010/102
Unilateral leg swellingGeneral disorders0/1011/102
ThrushInfections and infestations0/1011/102

Baseline characteristics

Age, Customized
Age, Customized(Participants)AQUACEL® Ag+ Extra™Cutimed® Sorbact®Total
< 65384280
65-79444185
80+191938
Sex: Female, Male
Sex: Female, Male(Participants)AQUACEL® Ag+ Extra™Cutimed® Sorbact®Total
Female7156127
Male304676
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)AQUACEL® Ag+ Extra™Cutimed® Sorbact®Total
Count of participants——0
Region of Enrollment
Region of Enrollment(Participants)AQUACEL® Ag+ Extra™Cutimed® Sorbact®Total
Colombia5959118
United Kingdom202242
Germany222143
BMI
BMI(kg/m2)AQUACEL® Ag+ Extra™Cutimed® Sorbact®Total
Mean31.84 ± 8.2630.06 ± 6.1230.95 ± 7.19
08

Study locations

18 sites
  • Convatec Colombia Clinic
    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
  • Germany
    Augsburg, Germany
  • Germany
    Berlin, Germany
  • Germany
    Bochum, Germany
  • Germany
    Düsseldorf, Germany
  • Germany
    Holzkirchen, Germany
  • Germany
    Ingolstadt, Germany
  • Germany Clinic II
    München, Germany
  • Germany Clinic I
    München, Germany
  • Germany
    Nuremberg, Germany
  • Germany
    Ratzeburg, Germany
  • Germany
    Rosenheim, Germany
  • VCTC UK
    Derby, United Kingdom
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 16, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05892341
Lead sponsor
ConvaTec Inc.
Collaborators
NAMSA
Responsible party
Sponsor
First posted
Jun 7, 2023
Start date
Dec 5, 2022
Primary completion
Feb 14, 2024
Completion
Feb 14, 2024
Results posted
Dec 2, 2025
Last update
Dec 2, 2025

Study contacts

Catarina Saavedra, MD
principal investigator · Convatec Colombia Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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