Evaluation of Granulox as adjunct therapy for chronic VLU vs SoC
Research type
Research Study
Full title
Multicentre, prospective, randomized, open-label, assessor blinded study to evaluate Granulox® used as adjunct therapy to defined standard of care vs. defined standard of care for the treatment of predominantly chronic venous leg ulcers (VLUs)
IRAS ID
286028
Contact name
Karen Staines
Contact email
Sponsor organisation
Mölnlycke Health Care AB
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 25 days
Research summary
Granulox® is a CE marked medical device for the treatment of chronic wounds such as arterial leg ulcer, mixed leg ulcer, diabetic foot ulcers, secondary healing of surgical wounds and pressure sores. Granulox can also be used on sloughy and infected wounds. It is intended to increase oxygen supply to the wound and so aid healing by promoting the formation of new blood vessels and growth of new skin, and avoiding a death of cell or tissue that might result from oxygen deficiency.
Granulox provides the wound with the required oxygen by means of diffusion. The active substance haemoglobin supplies the base of the wound with external oxygen, and this improved oxygen supply to the base of the wound supports wound healing.
The purpose of this investigation is to confirm if the haemoglobin spray Granulox® improves the healing of chronic venous leg ulcers (VLUs) over a period of 20 weeks, compared to standard of care. It will involve 8 clinic visits. Between each clinic visit a care nurse will visit per standard of care, every 1, 2 or 3 days as requested by the study doctor, to cleanse the wound, remove any dead or unhealthy tissue, apply Granulox spray (if allocated), and apply new dressings and compression therapy. Participants not allocated to receive Granulox will receive exactly the same standard of care in all other respects. A diary will be completed at each home visit to confirm the nurses activities and record any comments.
Approximately 254 participants will be enrolled on this study in 7 countries in Europe.
REC name
London - Dulwich Research Ethics Committee
REC reference
20/PR/0320
Date of REC Opinion
27 Oct 2020
REC opinion
Further Information Favourable Opinion