Venous Leg UlcerBISILNCT05786612
Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care
A study testing Biatain® Silicone and Mepilex Border with Aquacel Extra Hydrofiber in people with Venous Leg Ulcer and Diabetic Foot Ulcer, run by Coloplast A/S at 9 sites in United Kingdom.
Trial summary
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) This study (BISIL) will compare the Biatain® Silicone dressing to commonly used wound care products… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer, Diabetic Foot Ulcer
- What is being tested?
- Biatain® Silicone and Mepilex Border with Aquacel Extra Hydrofiber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 30 Jan 2023to 27 Dec 2023
- 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 given written consent to participate by signing the Informed Consent Signature Form
- Is at least 18 years of age and has full legal capacity
- Has a venous leg ulcer (VLU) (C6 of the CEAP classification(1)) or a non-infected diabetic foot ulcer (DFU) with a duration longer than 8 weeks but no longer than 24 months
- Has a wound with depth1 down to 20 mm
- Has a maximum wound depth1 relative to wound diameter
- Has a wound with exudate levels requiring a filler and a standard secondary dressing
- Has acceptance of compression therapy in case of a VLU or off-loading in case of a DFU, according to local standards
- For subjects with diabetes, has HbA1c ≤ 10% or ≤ 86 mmol/mol, measured within the last 3 months prior to inclusion
Who cannot join
- Wound is infected. For DFUs, has infection severity mild-severe according to the IWGDF/IDSA guideline For VLUs, has 2 or more clinical signs of infection as defined in protocol, based on clinical judgement by investigator/tissue viability nurse
- Wounds is with exposed tendons, is with bones or has fistulas
- Wound is with cavity, or is undermined or tunnelling
- Subject is receiving chemotherapy
- Subject has ankle-brachial pressure index (ABPI) below 0.8 measured within one month prior to inclusion
- Wound is larger than 10 x10 cm
- Currently enrolled in another wound care de-vice investigation unless co-enrolment has been agreed with the sponsor
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Northumbria Healthcare
Ashington, NE63 0HP
North Cumbria Integrated Care
Carlisle, Cumbria, CA2 7HY
Pioneer Wound care and Lymphoedema Centres
Eastbourne, BN23 8AS
Leeds Teaching Hospitals
Leeds, West Yorkshire, LS9 7TF
Homerton Hospital
London, Greater London, E9 6SR
Milton Keynes University Hospital
Milton Keynes, Buckinghamshire, MK6 5LD
Norfolk Community Health and Care NHS Trust
Norwich, Bowthorpe Road Norwich, NR2 3TU
Somerset NHS Foundation Trust
Taunton, Somerset, TA1 5DA
Torbay and South Devon
Torquay, Torbay, TQ2 7AA
About this study
Official title: A Randomised Controlled Investigation Comparing the Clinical Performance and Cost Effectiveness of Biatain® Silicone With Standard of Care Dressing Including Filler in Chronic Wounds
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study)
This study (BISIL) will compare the Biatain® Silicone dressing to commonly used wound care products (AQUACEL®EXTRATM Hydrofiber® Dressing used with Mepilex® Border).
The study will recruit in total 100 adult subjects with a venous leg ulcer or a diabetic foot ulcer no deeper than 2cm. Only ulcers with a duration of at least 8 weeks but no longer than a year will be included. The study will be a randomised controlled trial where half of the participants will use Biatain® Silicone and half will use the comparator for 4 weeks. Each participant will be in the study for 4-5 weeks during which there will be a weekly visit with the study team to complete the study assessments and change the dressing. The study will run for approximately one year, starting in January 2023.
Read the detailed description
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study)
The properties of a wound dressing can have a significant impact on wound healing and on the risk of developing infections. The ideal wound dressing should have good contact with the wound and be effective in absorbing and holding fluids. Biatain® Silicone uses 3DFit technology, which may support better contact with the wound, help to absorb fluid more effectively and reduce the risk of leakage. These properties may support faster wound healing and reduce complications.
This study (BISIL) will compare the Biatain® Silicone dressing to commonly used wound care products (AQUACEL®EXTRATM Hydrofiber® Dressing used with Mepilex® Border). All products used in this study are CE-marked medical devices which are already available in the UK. The main objective is to compare the reduction in wound area over four weeks between the two treatment groups. The study will also look at other aspects of wound healing and compare the costs of the dressings and the participants' quality of life during the study period. In a subgroup of participants, ultrasound will be used to assess the contact between the dressings and the wound.
The study will recruit in total 100 adult subjects with a venous leg ulcer or a diabetic foot ulcer no deeper than 2cm. Only ulcers with a duration of at least 8 weeks but no longer than a year will be included. Participants will be inpatients or outpatients recruited through 12-18 Tissue Viability Units and hospitals across the UK. The study will be a randomised controlled trial where half of the participants will use Biatain® Silicone and half will use the comparator for 4 weeks. Each participant will be in the study for 4-5 weeks during which there will be a weekly visit with the study team to complete the study assessments and change the dressing. The study will run for approximately one year, starting in January 2023.
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer
- Being tested
- Biatain® Silicone, Mepilex Border with Aquacel Extra Hydrofiber
- Medical subject headings
- Varicose Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biatain® SiliconeDevice
Wound care dressing
Mepilex Border with Aquacel Extra HydrofiberDevice
Wound care dressing
| Study group | Role | What they receive |
|---|---|---|
| Mepilex Border with Aquacel Extra Hydrofiber | Active comparator | Standard of care (filler, that functions as a primary dressing to manage exudate and the gap/space between the wound bed and the dressing, covered by a secondary dressing on top) defined in this study as Mepilex® Border with AQUACEL® Extra Hydrofiber Dressing Receives: Device: Mepilex Border with Aquacel Extra Hydrofiber |
| Biatain® Silicone | Experimental | The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management and can be used without a filler. Receives: Device: Biatain® Silicone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Wound Area Reduction (WAR) During Four Weeks
Photos of the wounds were collected at every site visit. A ruler or marker was used for calibration of linear dimensions at the image. Wound size reduction between visit 5 and at baseline was calculated. The mean WAR for each treatment group was calculated. As wounds would become smaller over time, the baseline wound size minus the wound size at visit 5 would be a positive value. If the value is negative this means the wound size has grown in size.
Measured: Baseline and four weeks
Secondary outcomes (1)
Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products
Total cost, £, was calculated as the number of products used multiplied by the unit price of the product. The price was extracted from the Drug Tariff on the date of Last Patient Out.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start30 Jan 2023
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The clinical investigation is a two-arms, open-labelled, stratified, randomized, controlled, multicentre investigation comparing the clinical performance of Biatain® Silicone with standard of care in chronic wounds with wound depth down to 20 mm.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Voegeli, Study chair, University of Winchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786612
- Sponsor's protocol ID
- CP351
- Acronym
- BISIL
- Status last verified
- Feb 2025
- First submitted
- 18 Jan 2023
- Last updated
- 5 Mar 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Investigation Comparing the Clinical Performance and Cost Effectiveness of Biatain® Silicone With Standard of Care Dressing Including Filler in Chronic Wounds
- ClinicalTrials.gov ID
- NCT05786612
- Acronym / sponsor ID
- BISIL / CP351
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Posted 5 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study)
This study (BISIL) will compare the Biatain® Silicone dressing to commonly used wound care products (AQUACEL®EXTRATM Hydrofiber® Dressing used with Mepilex® Border).
The study will recruit in total 100 adult subjects with a venous leg ulcer or a diabetic foot ulcer no deeper than 2cm. Only ulcers with a duration of at least 8 weeks but no longer than a year will be included. The study will be a randomised controlled trial where half of the participants will use Biatain® Silicone and half will use the comparator for 4 weeks. Each participant will be in the study for 4-5 weeks during which there will be a weekly visit with the study team to complete the study assessments and change the dressing. The study will run for approximately one year, starting in January 2023.
Detailed description
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study)
The properties of a wound dressing can have a significant impact on wound healing and on the risk of developing infections. The ideal wound dressing should have good contact with the wound and be effective in absorbing and holding fluids. Biatain® Silicone uses 3DFit technology, which may support better contact with the wound, help to absorb fluid more effectively and reduce the risk of leakage. These properties may support faster wound healing and reduce complications.
This study (BISIL) will compare the Biatain® Silicone dressing to commonly used wound care products (AQUACEL®EXTRATM Hydrofiber® Dressing used with Mepilex® Border). All products used in this study are CE-marked medical devices which are already available in the UK. The main objective is to compare the reduction in wound area over four weeks between the two treatment groups. The study will also look at other aspects of wound healing and compare the costs of the dressings and the participants' quality of life during the study period. In a subgroup of participants, ultrasound will be used to assess the contact between the dressings and the wound.
The study will recruit in total 100 adult subjects with a venous leg ulcer or a diabetic foot ulcer no deeper than 2cm. Only ulcers with a duration of at least 8 weeks but no longer than a year will be included. Participants will be inpatients or outpatients recruited through 12-18 Tissue Viability Units and hospitals across the UK. The study will be a randomised controlled trial where half of the participants will use Biatain® Silicone and half will use the comparator for 4 weeks. Each participant will be in the study for 4-5 weeks during which there will be a weekly visit with the study team to complete the study assessments and change the dressing. The study will run for approximately one year, starting in January 2023.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The clinical investigation is a two-arms, open-labelled, stratified, randomized, controlled, multicentre investigation comparing the clinical performance of Biatain® Silicone with standard of care in chronic wounds with wound depth down to 20 mm.
| Arm | Type | Receives |
|---|---|---|
| Mepilex Border with Aquacel Extra Hydrofiber | Active comparator | Device: Mepilex Border with Aquacel Extra HydrofiberStandard of care (filler, that functions as a primary dressing to manage exudate and the gap/space between the wound bed and the dressing, covered by a secondary dressing on top) defined in this study as Mepilex® Border with AQUACEL® Extra Hydrofiber Dressing |
| Biatain® Silicone | Experimental | Device: Biatain® SiliconeThe investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management and can be used without a filler. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has given written consent to participate by signing the Informed Consent Signature Form
- Is at least 18 years of age and has full legal capacity
- Has a venous leg ulcer (VLU) (C6 of the CEAP classification(1)) or a non-infected diabetic foot ulcer (DFU) with a duration longer than 8 weeks but no longer than 24 months
- Has a wound with depth1 down to 20 mm
- Has a maximum wound depth1 relative to wound diameter
Key exclusion criteria (7 listed)
- Wound is infected. For DFUs, has infection severity mild-severe according to the IWGDF/IDSA guideline For VLUs, has 2 or more clinical signs of infection as defined in protocol, based on clinical judgement by investigator/tissue viability nurse
- Wounds is with exposed tendons, is with bones or has fistulas
- Wound is with cavity, or is undermined or tunnelling
- Subject is receiving chemotherapy
- Subject has ankle-brachial pressure index (ABPI) below 0.8 measured within one month prior to inclusion
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® SiliconeWound care dressing | Device | Biatain® Silicone |
| Mepilex Border with Aquacel Extra HydrofiberWound care dressing | Device | Mepilex Border with Aquacel Extra Hydrofiber |
Primary outcome
Percentage Wound Area Reduction (WAR) During Four Weeks
Time frame: Baseline and four weeks
Photos of the wounds were collected at every site visit. A ruler or marker was used for calibration of linear dimensions at the image. Wound size reduction between visit 5 and at baseline was calculated. The mean WAR for each treatment group was calculated. As wounds would become smaller over time, the baseline wound size minus the wound size at visit 5 would be a positive value. If the value is negative this means the wound size has grown in size.
1 secondary outcome
Total Treatment Costs, £, During 4 Weeks Based on the Number of Dressings Used and the Unit Price in £ of the Products
Time frame: Baseline to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 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.
David Voegeli study chair
University of Winchester
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biatain® Silicone and Mepilex Border with Aquacel Extra Hydrofiber in people with Venous Leg Ulcer and Diabetic Foot Ulcer, run by Coloplast A/S at 9 sites 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 8 inclusion and 7 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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 5 Mar 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?
Percentage Wound Area Reduction (WAR) During Four Weeks (time frame: Baseline and four 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 5 Mar 2025.