Ulcer FootNCT07308665
Aquacel With Strengthening Fiber (WSF) Ribbon Dressings
An observational study of Ulcer Foot and Ulcer Healing, run by ConvaTec Inc..
Trial summary
Retrospective, multi-site, non-comparative, post-market study Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulcer Foot, Ulcer Healing, Wound Infection
- What is being tested?
- Aquacel Ribbon
- Type of treatment
- Medical device
- How many people
- 214 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 17 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients who received an Aquacel WSF Ribbon dressing and who's data was collected in Wound Care Advantage (WCA).
Who may be able to join
- Subjects who have received one or more Aquacel WSF Ribbon dressing
Who cannot join
- Patients who have not received one or more Aquacel WSF Ribbon dressings
About this study
Official title: A Multi-site Retrospective Study of the Real-world Performance of Aquacel With Strengthening Fiber (WSF) Ribbon Dressings
Retrospective, multi-site, non-comparative, post-market study
Read the detailed description
Retrospective, multi-site, non-comparative, post-market study to evaluate real-world performance of Aquacel WSF Ribbon dressings in wound healing
- Conditions
- Ulcer Foot, Ulcer Healing, Wound Infection
- Being tested
- Aquacel Ribbon
- Medical subject headings
- Foot Ulcer, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquacel RibbonDevice
Subjects who received an Aquacel WSF Ribbon
| Study group | Role | What they receive |
|---|---|---|
| Aquacel Ribbon | Aquacel WSF Ribbon treatment Receives: Device: Aquacel Ribbon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and week 4, 12, 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Jan 2017
- Primary completion8 Apr 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcer FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Mastandrea, Study director, ConvaTec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308665
- Sponsor's protocol ID
- WC-24-450
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site Retrospective Study of the Real-world Performance of Aquacel With Strengthening Fiber (WSF) Ribbon Dressings
- ClinicalTrials.gov ID
- NCT07308665
- Acronym / sponsor ID
- WC-24-450
- Conditions
- Ulcer Foot, Ulcer Healing, Wound Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective, multi-site, non-comparative, post-market study
Detailed description
Retrospective, multi-site, non-comparative, post-market study to evaluate real-world performance of Aquacel WSF Ribbon dressings in wound healing
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquacel Ribbon | – | Device: Aquacel RibbonAquacel WSF Ribbon treatment |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received an Aquacel WSF Ribbon dressing and who's data was collected in Wound Care Advantage (WCA).
Key inclusion criteria (1 listed)
- Subjects who have received one or more Aquacel WSF Ribbon dressing
Key exclusion criteria (1 listed)
- Patients who have not received one or more Aquacel WSF Ribbon dressings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquacel RibbonSubjects who received an Aquacel WSF Ribbon | Device | Aquacel Ribbon |
Primary outcome
Real-world efficacy of Aquacel WSF Ribbon in improving the incidence of wound closure
Time frame: Baseline and week 4, 12, 20
Time to complete wound closure, defined as 100% epithelialization of the wound surface
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
Related trials for Ulcer Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Mastandrea study director
ConvaTec Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcer Foot and Ulcer Healing, run by ConvaTec Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world efficacy of Aquacel WSF Ribbon in improving the incidence of wound closure (time frame: Baseline and week 4, 12, 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.