Biovotec
Research type
Research Study
Full title
A multi-centre, pilot, prospective, trial of DermaRep™ Device in the treatment of venous leg ulcers
IRAS ID
214921
Contact name
Kevin Mercer
Contact email
Sponsor organisation
Biovotec AS
Duration of Study in the UK
0 years, 10 months, 27 days
Research summary
This is a multi-centre, pilot, prospective trial of the DermaRep™ Device in the treatment of Venous Leg Ulcers, where 40 participants will be recruited from up to 6 sites in the UK. Wound healing can be difficult and wounds which fail to heal can sometimes end up in a vicious circle of inflammation, tissue desrruction and/or infection. DermaRep™ has been developed to remove these difficulties in healing. DermaRep™ is a wound dressing consisting of purified egg protein (PEP), and when applied to the wound it helps to create an ideal optimal healing environment. The objective of this study is to look at the safety of the DermaRep™ Device. DermaRep™ is intended to be used in addition to standard of care. Participants who have provided written informed consent will receive standard of care treatment for 4 weeks known as a run-in period, to confirm the status of the wound. At the end of the run-in period, participants who continue to meet the inclusion criteria will then receive treatment with DermaRep™. Participants will be treated with the DermaRep™, with wound dressing changes as per standard of care weekly for up to 8 weeks. For those participants whose wounds have not healed by Week 8 will be followed up weekly as per standard of care for Week 9-11. All participants will be required to attend a final assessment at Week 12. During the follow up visits and final assessment visit, the wound will be assessed, and wound tracings and photographs of the wound will be taken.\n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
18/YH/0136
Date of REC Opinion
9 Jul 2018
REC opinion
Further Information Favourable Opinion