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Completed

NCT Number: NCT07308678

AQUACEL® Ag+ Extra™ vs Cutimed® Sorbact®

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).

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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Essen University Hospital

Essen, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Other outcomes

  1. Inter-rater reliability of photographic assessment

    Time frame: up to 12 week

    Inter-rater reliability (IRR) of photographic to live assessment of wound closure

  2. 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

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2025
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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