HAWS - Haemoglobin Application to Wounds Study
Research type
Research Study
Full title
Haemoglobin Application to Wounds Study, a single-centre, controlled, prospective, randomized trial of Granulox haemoglobin spray for adjuvant treatment of diabetic foot ulcers.
IRAS ID
227421
Contact name
Stacey Fisher
Contact email
Sponsor organisation
Cumbria Partnership NHS Foundation Trust
Duration of Study in the UK
1 years, 2 months, 30 days
Research summary
Diabetes can lead to various complications in affected people, including diabetic foot ulcer. DFU carries with it high levels of morbidity. If a DFU develops, it is important to treat it appropriately in order to optimise the chance of the DFU healing and minimise the risk of infection, respectively. The application of dressings and so-called offloading of the DFU area reduces the strain on the wound area and keeps it clean. To allow optimal healing of the wound, it is essential to have sufficiently high oxygen levels. Hypoxia, can lead to necrosis and deterioration of the wound. Oxygen promotes the formation of new blood vessels and subsequently the growth of new skin.
New treatment modalities have been introduced to increase oxygen levels in wounds, including hyperbaric oxygen (HBO) treatment. However, such treatments tend to be cumbersome, time-intensive and costly. In the UK, InFirst Ltd has brought to market a new medical device for oxygen treatment, which is designed to be more straightforward to apply than HBO. The product, Granulox, contains porcine haemoglobin contained in a spray canister. It is applied twice weekly to a DFU wound during redressing, and can be used in a clinic or patient’s home setting. Initial case series and retrospective comparative studies have shown that Granulox reduces the time for a DFU to heal.
This study seeks to assess if Granulox has a significant positive impact on the rate of wound healing in DFUs. For the first time, a prospective randomised approach is taken. Participants will receive standard care or standard care plus Granulox spray twice weekly for up to 12 weeks or until the DFU is healed. The effects of the trial treatment on participants’ quality of life and its safety will also be appraised.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0237
Date of REC Opinion
17 Jul 2017
REC opinion
Further Information Favourable Opinion