NCT07308665

Brief Summary

Retrospective, multi-site, non-comparative, post-market study

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

8.3 years

First QC Date

December 17, 2025

Last Update Submit

December 17, 2025

Conditions

Ulcer FootUlcer HealingWound Infection

Outcome Measures

Primary Outcomes (1)

  • Real-world efficacy of Aquacel WSF Ribbon in improving the incidence of wound closure

    Time to complete wound closure, defined as 100% epithelialization of the wound surface

    Baseline and week 4, 12, 20

Other Outcomes (6)

  • Wound size

    Baseline and week 4, 12, 20

  • Wound dept

    Baseline and week 4, 12, 20

  • Exudate volume

    Baseline and week 4, 12, 20

  • +3 more other outcomes

Study Arms (1)

Aquacel Ribbon

Aquacel WSF Ribbon treatment

Device: Aquacel Ribbon

Interventions

Aquacel RibbonDEVICE

Subjects who received an Aquacel WSF Ribbon

Aquacel Ribbon

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received an Aquacel WSF Ribbon dressing and who's data was collected in Wound Care Advantage (WCA).

You may qualify if:

  • Subjects who have received one or more Aquacel WSF Ribbon dressing

You may not qualify if:

  • Patients who have not received one or more Aquacel WSF Ribbon dressings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Foot UlcerWound Infection

Condition Hierarchy (Ancestors)

Foot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin UlcerInfections

Study Officials

  • Christina Mastandrea

    ConvaTec Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

December 30, 2025

Study Start

January 1, 2017

Primary Completion

April 8, 2025

Study Completion

September 17, 2025

Last Updated

December 30, 2025

Record last verified: 2025-12