AQUACEL® Ag+ Extra™ vs Cutimed® Sorbact® | NCT07308678

Studies
AQUACEL® Ag+ Extra™ vs Cutimed® Sorbact®

NCT07308678

Sponsor

ConvaTec Inc.

Status

Completed

Last Update Posted

Jan 8, 2026Actual

Enrollment

105Actual

Phase

Not provided

Conditions

Venous Leg Ulcer
Diabetic Foot

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2025Actual

Primary Completion Date

May 28, 2025Actual

Completion Date

May 28, 2025Actual

First Submitted Date

Dec 17, 2025

First Submission Date that Met QC Criteria

Dec 17, 2025

First Posted Date

Dec 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2026

Last Update Posted Date

Jan 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound closure at 12 weeks	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

Secondary Outcomes

Not provided

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joachim Dissemond, MD	Essen University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Essen University Hospital		Essen			Germany

Condition Browse Module

MeSH Terms

ID	Term
D014647	Varicose Ulcer
D017719	Diabetic Foot

Ancestor Terms

ID	Term
D014648	Varicose Veins
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007871	Leg Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided