Wound HealNCT05923749
A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers
A study testing Biatain Ag and Cutimed Siltec Sorbact in people with Wound Heal, run by Coloplast A/S at 13 sites in 4 countries.
Trial summary
Approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- Biatain Ag and Cutimed Siltec Sorbact
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 29 Jun 2023to 29 Jan 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signed informed consent
- Is above 18 years of age or above and has full legal capacity
- Has venous leg ulcer (C6 of the CEAP classification) with a duration longer than 4 weeks but no longer than 5 years
- Has acceptance of compression bandages
- Has a wound at risk of infection based on WAR (wounds at risk of infection) score with score of ≥3 points OR has at least three of the following clinical signs of bacterial contamination based on the Therapeutic index for local infections (TILI) score:
- Erythema to surrounding skin
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- Heat
- Oedema, induration or swelling
- Spontaneous pain or pressure pain
- Stalled wound healing
- Increase and/or change of color or smell of exudate
- Has wound area of min 1x1 cm and max 10x10 cm
- Has wound with depth of max 2 cm
- Has wound with medium to high level of exudate (but should not require more than 1 dressing change/day)
- Has ankle-brachial pressure (ABI) ≥0.8 AND, for patients with diabetes mellitus, additional biphasic Doppler signal up to the ankle
- Ability (assessed by the investigator) and willingness to adhere to a 1-month intervention period
- For patients with diabetes, has HbA1c ≤ 10%/≤ 86 mmol/mol, measured within the last 3 months prior to inclusion
- Should be able to follow the study protocol with the prescribed cleansing product (NaCl) and dressing
Who cannot join
- Is pregnant or breastfeeding
- Has wounds with exposed tendons, bones, fistulas. Or wounds with cavity, undermined or tunnelling
- Has infection requiring antibiotics (also for other reasons than wound infection) OR has received antibiotics within the last 1 week before inclusion
- Has been receiving the following medical treatment within the last 4 weeks: immunosup-pression, immunomodulating, cytostatic medi-cation or corticoids (topical except for in the wound, inhalation, and stable systemic treat-ment up to 5 mg per day (stable defined as minimum 4 weeks) is allowed
- Has a systemic hematological disease
- Has renal insufficiency requiring dialysis
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- Has advanced heart failure NYHA III/IV
- Has a psychiatric illness that inhibits compliance with the study protocol
- Has severe congenital immunodeficiency such agammaglobulinemia, severe combined immunodeficiency (SCID)
- Has allergy towards silver or other dressing ingredients (including compression therapy)
- Has wound with > 50% necrotic tissue
- Treatment of wound with an anti-microbial wound dressing within the last 2 weeks
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Germany6 sites
Wundmanagement Gefäßzentrum Aachen Wundmanagement
Aachen, 52066
Katholisches Klinikum Bochum
Bochum, 44791
Krankenhaus Buchholz und Winsen gemeinnüzige GmbH
Buchholz, 21244
ProDerma
Dülmen, 48249
Universitätsklinikum Erlangen
Erlangen, 91054
Universitätsklinikum Giessen und Marburg GmbH
Giessen, 35385
United States5 sites
Detroit foot and ankle Specialists
Clinton Township, Michigan, 48038
Royal Research, Corp.
Hollywood, Florida, 33021
Serena Group
Monroeville, Pennsylvania, 15146
Three Rivers Wound and Research Center
North Port, Florida, 34289
SerenaGroup Research Center Omaha
Omaha, Nebraska, 68114
United Kingdom1 site
Pioneer Wound Healing and Lymphedema centres
Eastbourne, BN23 8AS
About this study
Official title: A Prospective Randomised Controlled Study Demonstrating the Clinical Benefit of Biatain® Ag Relative to Cutimed® Siltec® Sorbact® for the Treatment of Venous Leg Ulcers
Approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.
- Conditions
- Wound Heal
- Being tested
- Biatain Ag, Cutimed Siltec Sorbact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biatain AgDevice
Biatain with silver
Cutimed Siltec SorbactDevice
comparator device
| Study group | Role | What they receive |
|---|---|---|
| Biatain Ag | Experimental | Not described Receives: Device: Biatain Ag |
| Cutimed Siltec Sorbact | Active comparator | Not described Receives: Device: Cutimed Siltec Sorbact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Relative wound area change measured by calculation of area based on photo of wound
Measured: After 4 weeks
Secondary outcomes (3)
Wound area reduction
Reaching ≥ 40% wound area change
Measured: After 4 weeks
Wound healing
Wounds healed after 12 weeks (yes/no assessed by investigator)
Measured: After 12 weeks
Quality of Life (based on Wound-Quality of Life-17 questionnaire)
Patient Quality of Life
Measured: After 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start29 Jun 2023
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- Masking
- None (open label)
- Enrolment
- 180 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
- NCT05923749
- Sponsor's protocol ID
- CP354
- Status last verified
- May 2025
- First submitted
- 14 Jun 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Controlled Study Demonstrating the Clinical Benefit of Biatain® Ag Relative to Cutimed® Siltec® Sorbact® for the Treatment of Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT05923749
- Acronym / sponsor ID
- CP354
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 28 Jun 2023 (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.
Approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biatain Ag | Experimental | Device: Biatain Ag |
| Cutimed Siltec Sorbact | Active comparator | Device: Cutimed Siltec Sorbact |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Has signed informed consent
- Is above 18 years of age or above and has full legal capacity
- Has venous leg ulcer (C6 of the CEAP classification) with a duration longer than 4 weeks but no longer than 5 years
- Has acceptance of compression bandages
- Has a wound at risk of infection based on WAR (wounds at risk of infection) score with score of ≥3 points OR has at least three of the following clinical signs of bacterial contamination based on the Therapeutic index for local infections (TILI) score:
Key exclusion criteria (12 listed)
- Is pregnant or breastfeeding
- Has wounds with exposed tendons, bones, fistulas. Or wounds with cavity, undermined or tunnelling
- Has infection requiring antibiotics (also for other reasons than wound infection) OR has received antibiotics within the last 1 week before inclusion
- Has been receiving the following medical treatment within the last 4 weeks: immunosup-pression, immunomodulating, cytostatic medi-cation or corticoids (topical except for in the wound, inhalation, and stable systemic treat-ment up to 5 mg per day (stable defined as minimum 4 weeks) is allowed
- Has a systemic hematological disease
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 AgBiatain with silver | Device | Biatain Ag |
| Cutimed Siltec Sorbactcomparator device | Device | Cutimed Siltec Sorbact |
Primary outcome
Wound healing
Time frame: After 4 weeks
Relative wound area change measured by calculation of area based on photo of wound
3 secondary outcomes
Wound area reduction
Time frame: After 4 weeks
Wound healing
Time frame: After 12 weeks
Quality of Life (based on Wound-Quality of Life-17 questionnaire)
Time frame: After 4 and 12 weeks
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 22 May 2025.
- 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.
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biatain Ag and Cutimed Siltec Sorbact in people with Wound Heal, run by Coloplast A/S at 13 sites in 4 countries.
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 18 inclusion and 12 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 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, United States, Denmark, 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?
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?
Wound healing (time frame: After 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 22 May 2025.