AQUACEL® Ag+ Extra™ vs Cutimed® Sorbact®

NCT ID: NCT07308678

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-22
• Study Completion Date: 2025-05-28

Brief Summary

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).

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).

Conditions

Venous Leg Ulcer; Diabetic Foot

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ConvaTec Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joachim Dissemond, MD

Role: PRINCIPAL_INVESTIGATOR

Essen University Hospital

Locations

Essen University Hospital

Essen, , Germany

Countries

Germany

Other Identifiers

WC-25-463

Identifier Type: -

Identifier Source: org_study_id