Venous Leg UlcerNCT05873257
Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers
A study testing Biatain Fiber Ag applied to participants in people with Venous Leg Ulcer, run by Coloplast A/S at 1 site in United Kingdom.
Trial summary
The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a venous leg ulcer Participants will be asked to wear the test dressing in a four weeks period (+/- 2 days) consisting of 6 study visits, and will have the dressing changed once pr. week at the research facility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Biatain Fiber Ag applied to participants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2023to 17 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signed informed consent
- Is 18 years or above
- Is capable of following study procedure (assessed by the investigator).
- Has a venous leg ulcer that has failed to progress along the expected wound healing trajectory within 4 weeks
- The shape of the wound should be possible to fit under a 10x10 cm dressing
- The shape and location of the wound should be suitable for photo capture (assessed by the investigator).
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- Has at least three of five pre-defined clinical signs of infection; pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour, or heavy exudate (assessed by the investigator).
- Has a wound that has medium to high level of exudate (assessed by the investigator).
- Has an ankle to brachial pressure index (ABPI) of 0.8 -1.3
- Agrees to wear compression therapy daily in combination with the test dressing
- Is suitable to use the test product for wound treatment (assessed by the investigator).
Who cannot join
- Is pregnant/breastfeeding
- Wound is older than 12 months
- Wound with exposed tendons or bones or has fistulas
- Wound which is undermined or tunneling
- Is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area)
- Known history of skin sensitivity to any components of the treatment dressings
- Intake of antibiotics within one week before the start of the enrolment
- Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria Healthcare NHS foundation trust
Ashington, Northumbria, NE630HP
About this study
Official title: Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcer
The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a venous leg ulcer
Participants will be asked to wear the test dressing in a four weeks period (+/- 2 days) consisting of 6 study visits, and will have the dressing changed once pr. week at the research facility. The wound will be cleaned, assessed and photos will be uploaded to a digital software system.
Read the detailed description
: The clinical investigation is a non-comparative, one-armed, open-labelled, multi-centre study
The test product, Biatain Fiber Ag is a non-CE-marked gelling fiber wound dressing, containing silver. The product is intended for moist wound healing and exudate management of moderate to high exuding wounds.
The overall purpose of this investigation is to obtain clinical data supporting effectiveness of Biatain Fiber Ag to obtain the CE-mark in EU.
The total study duration for the subject will be approximately four weeks, consisting of a four-week test period and 6 study visits (V0/V1, V2, V3, V4 and V5). V5 will also terminate the 4-week study period.
The primary endpoint is Mean area wound reduction. The endpoint is used to evaluate clinical performance in terms of relative wound area reduction as an indication of total wound healing.
- Conditions
- Venous Leg Ulcer
- Being tested
- Biatain Fiber Ag applied to participants
- Keywords
- wound healing
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biatain Fiber Ag applied to participantsDevice
Intervention involving a wound gelling fiber dressing with silver
| Study group | Role | What they receive |
|---|---|---|
| main arm | Other | Non comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a four weeks period with planned dressing changes once pr. week. Receives: Device: Biatain Fiber Ag applied to participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Relative Wound Area Reduction as Indication of Total Wound Healing
Wound area will be measured by obtaining photos of the wounds and measure these afterwards. A planimetric software will be used where the wound is photographed with a ruler of known dimensions placed at the skin near the wound edge and the image is transferred to a computer and opened in the planimetric software. The ruler is used for calibration of linear dimensions at the image. Once the wound border is manually traced with a computer mouse the area of wound is calculated and displayed.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start31 Jul 2023
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous Leg UlcerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-comparative, one-armed, open-labelled, multi-centre study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873257
- Sponsor's protocol ID
- CP358
- Status last verified
- May 2025
- First submitted
- 1 May 2023
- Last updated
- 3 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcer
- ClinicalTrials.gov ID
- NCT05873257
- Acronym / sponsor ID
- CP358
- Conditions
- Venous Leg Ulcer
- Keywords
- wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Posted 3 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a venous leg ulcer
Participants will be asked to wear the test dressing in a four weeks period (+/- 2 days) consisting of 6 study visits, and will have the dressing changed once pr. week at the research facility. The wound will be cleaned, assessed and photos will be uploaded to a digital software system.
Detailed description
: The clinical investigation is a non-comparative, one-armed, open-labelled, multi-centre study
The test product, Biatain Fiber Ag is a non-CE-marked gelling fiber wound dressing, containing silver. The product is intended for moist wound healing and exudate management of moderate to high exuding wounds.
The overall purpose of this investigation is to obtain clinical data supporting effectiveness of Biatain Fiber Ag to obtain the CE-mark in EU.
The total study duration for the subject will be approximately four weeks, consisting of a four-week test period and 6 study visits (V0/V1, V2, V3, V4 and V5). V5 will also terminate the 4-week study period.
The primary endpoint is Mean area wound reduction. The endpoint is used to evaluate clinical performance in terms of relative wound area reduction as an indication of total wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-comparative, one-armed, open-labelled, multi-centre study
| Arm | Type | Receives |
|---|---|---|
| main arm | Other | Device: Biatain Fiber Ag applied to participantsNon comparative - One armed - open labelled Intervention - subjects will wear the test dressing in a four weeks period with planned dressing changes once pr. week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Has signed informed consent
- Is 18 years or above
- Is capable of following study procedure (assessed by the investigator).
- Has a venous leg ulcer that has failed to progress along the expected wound healing trajectory within 4 weeks
- The shape of the wound should be possible to fit under a 10x10 cm dressing
Key exclusion criteria (8 listed)
- Is pregnant/breastfeeding
- Wound is older than 12 months
- Wound with exposed tendons or bones or has fistulas
- Wound which is undermined or tunneling
- Is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area)
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 |
|---|---|---|
| Biatain Fiber Ag applied to participantsIntervention involving a wound gelling fiber dressing with silver | Device | main arm |
Primary outcome
Mean Relative Wound Area Reduction as Indication of Total Wound Healing
Time frame: 4 weeks
Wound area will be measured by obtaining photos of the wounds and measure these afterwards. A planimetric software will be used where the wound is photographed with a ruler of known dimensions placed at the skin near the wound edge and the image is transferred to a computer and opened in the planimetric software. The ruler is used for calibration of linear dimensions at the image. Once the wound border is manually traced with a computer mouse the area of wound is calculated and displayed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biatain Fiber Ag applied to participants in people with Venous Leg Ulcer, run by Coloplast A/S at 1 site in United Kingdom.
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 11 inclusion and 8 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 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 3 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Relative Wound Area Reduction as Indication of Total Wound Healing (time frame: 4 weeks). 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 3 Jun 2025.