Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers
Venous Leg Ulcer
About this trial
This is an interventional treatment trial for Venous Leg Ulcer focused on measuring wound healing
Eligibility Criteria
Inclusion Criteria: 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). 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). Exclusion Criteria: 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).
Sites / Locations
- Serena Group
Arms of the Study
Arm 1
Other
main arm
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.