At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years with full legal capacity
- ✓Venous leg ulcer (CEAP C6) or non-infected diabetic foot ulcer
- ✓Wound duration 8–24 months
- ✓Wound depth ≤20 mm with appropriate depth-to-diameter ratio
- ✕Active wound infection (DFU: mild-severe per IWGDF/IDSA; VLU: ≥2 clinical signs per protocol)
- ✕Exposed tendons, bone, or fistulas
- ✕Wound cavities, undermining, or tunneling
- ✕Currently receiving chemotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised Controlled Investigation Comparing the Clinical Performance and Cost Effectiveness of Biatain® Silicone With Standard of Care Dressing Including Filler in Chronic Wounds
In Brief
A clinical study evaluating Biatain® Silicone and Mepilex Border with Aquacel Extra Hydrofiber for Venous Leg Ulcer and Diabetic Foot Ulcer. Completed, enrolled 102 participants across 9 sites.
Detailed 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 (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.
Study Details
Timeline
Interventions
Wound care dressing
Wound care dressing