CP358 - Biatain Fiber Ag on VLU
Research type
Research Study
Full title
Investigation of the clinical performance of Biatain Fiber Ag on venous leg ulcers
IRAS ID
334686
Contact name
Debera Drew
Contact email
Sponsor organisation
Coloplast A/S
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
The overall purpose of the investigation is to obtain data supporting effectiveness of the final product to obtain the CE-mark.
Subjects will use the investigational device in a 4 week test period (+/- 2 days) and have a scheduled visit once per week, visits V2 - V5. V5 will also terminate the 4-week study period. unless a situation occurs where a subject terminates earlier than expected.
The majority of endpoints captured in the study are well known in wound care and similar to what is already done when assessing a wound but also test product specific endpoints like how easy removal in one piece are captured.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
23/LO/0885
Date of REC Opinion
2 Nov 2023
REC opinion
Favourable Opinion