AQUACEL® Ag+ Extra™ vs Cutimed® Sorbact®

January 6, 2026 updated by: ConvaTec Inc.

Wound Closure in Venous Leg Ulcers (VLUs) Treated With AQUACEL® Ag+ Extra™ vs Cutimed® Sorbact®: A Blinded Re-Assessment of Randomized Controlled Trial Findings

Study is to provide a blinded assessment of wound closure status utilizing photographs collected as per standard of care (SOC) during the AAA RCT (WC-22-435).

Study Overview

Status

Completed

Conditions

Detailed Description

The purpose of the study is to provide a blinded (treatment arm, timepoint) assessment of wound closure status utilizing photographs collected as per standard of care (SOC) during the AAA Randomized Controlled Trial (RCT) (WC-22-435).

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany
        • Essen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who have wound photographs of sufficient quality taken as per standard of care (SOC) during the AAA RCT (WC-22-435) that correspond to wound closure or their 12-week visit.

Description

Inclusion Criteria:

  • All subjects from the intention to treat (ITT) population with wound photograph(s) corresponding to the study visit date (WC-22-435) indicating wound closure or their 12-week visit, whichever came first

Exclusion Criteria:

  • Subjects whose photographs are deemed of insufficient quality to make determination of closure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound closure at 12 weeks
Time Frame: 12 week
Incidence of wound closure at 12 weeks, defined as 100% epithelialization of the wound surface, assessed by a blinded observer through photographic evidence
12 week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-rater reliability of photographic assessment
Time Frame: up to 12 week
Inter-rater reliability (IRR) of photographic to live assessment of wound closure
up to 12 week
Inter-rater reliability of photographic site assessment
Time Frame: up to 12 week
IRR of photographic to live assessment of wound closure, by study site
up to 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ConvaTec Inc.

Investigators

  • Principal Investigator: Joachim Dissemond, MD, Essen University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2025

Primary Completion (Actual)

May 28, 2025

Study Completion (Actual)

May 28, 2025

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Estimated)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WC-25-463

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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