N/A N=203 Randomized Treatment

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

Venous Leg Ulcer · Diabetic Foot

Bottom Line

View on ClinicalTrials.gov: NCT05892341 ↗

Enrolled (actual)

203

Serious AEs

4.4%

Results posted

Dec 2025

Primary outcome: Primary: Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management — 80; 60 Number of Wounds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: AQUACEL® Ag+ Extra™ (Device); Cutimed® Sorbact® (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: ConvaTec Inc.
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management	80; 60	—
SECONDARY Wound Healing Assessment	-62.66; -48.31	—
SECONDARY Wound Progress Assessment	81; 70	—
SECONDARY Wound Change Assessment	-90.33; -67.22	—
SECONDARY Safety Assesment	11; 27; 3; 6; 1; 4	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05892341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.