A Clinical Investigation Comparing the Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With SoC (BISIL)
Venous Leg Ulcer, Diabetic Foot Ulcer
About this trial
This is an interventional treatment trial for Venous Leg Ulcer
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Norfolk Community Health and Care NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Mepilex Border with Aquacel Extra Hydrofiber
Biatain® Silicone
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
The investigational test product is Biatain® Silicone. Biatain® Silicone is intended to be used for moist wound healing and exudate management.