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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biatain Ag | Experimental |
| |
| Cutimed Siltec Sorbact | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biatain Ag | Device | Biatain with silver |
| |
| Cutimed Siltec Sorbact |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | Relative wound area change measured by calculation of area based on photo of wound | After 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound area reduction | Reaching ≥ 40% wound area change | After 4 weeks |
| Wound healing | Wounds healed after 12 weeks (yes/no assessed by investigator) |
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Inclusion Criteria:
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:
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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Research, Corp. | Hollywood | Florida | 33021 | United States | ||
| Three Rivers Wound and Research Center |
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| Device |
comparator device |
|
| After 12 weeks |
| Quality of Life (based on Wound-Quality of Life-17 questionnaire) | Patient Quality of Life | After 4 and 12 weeks |
| North Port |
| Florida |
| 34289 |
| United States |
| Detroit foot and ankle Specialists | Clinton Township | Michigan | 48038 | United States |
| SerenaGroup Research Center Omaha | Omaha | Nebraska | 68114 | United States |
| Serena Group | Monroeville | Pennsylvania | 15146 | United States |
| Dermato-Venerologisk Afd | Copenhagen | 2400 | Denmark |
| Wundmanagement Gefäßzentrum Aachen Wundmanagement | Aachen | 52066 | Germany |
| Katholisches Klinikum Bochum | Bochum | 44791 | Germany |
| Krankenhaus Buchholz und Winsen gemeinnüzige GmbH | Buchholz | 21244 | Germany |
| ProDerma | Dülmen | 48249 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitätsklinikum Giessen und Marburg GmbH | Giessen | 35385 | Germany |
| Pioneer Wound Healing and Lymphedema centres | Eastbourne | BN23 8AS | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 15, 2025 | Jan 5, 2026 | 11 | ||
| Jan 13, 2026 | Jan 28, 2026 | 12 |