The topical haemoglobin spray Granulox® (Infirst Healthcare, London) has shown promising results in a study of 20 people with diabetic foot ulcers (DFUs). The spray, which was launched in England, Scotland and Wales in 2014, is designed to improve oxygen availability in the wound bed and thus aid wound healing.
The study, the largest of this product in the UK to date, was conducted in seven people with type 1 diabetes and 13 with type 2 diabetes, all of whom had a score of 2 out of a possible 6 on the Site, Ischemia, Neuropathy, Bacterial Infection, Area and Depth (SINBAD) scale, which assesses the severity of DFUs and risk factors that may affect healing. All DFUs were located beneath the ankle, and all had persisted for more than 12 weeks. Participants received the spray in addition to standard care, with no other changes to products, devices or practice compared with before the study. Granulox was administered on eight set occasions over the 4-week study period.
After 4 weeks, all participants reported a reduction in wound surface area, elimination of slough and an improvement in exudate levels. The average wound size reduction was 62.3% (median, 56%), with a quarter of participants reporting a 100% reduction. Even wounds that had persisted for 1 year or more reduced in size by an average of 24%. All participants with a previous wound bed slough, covering between 10% and 100%, were slough-free, with no debridement required. Significant reductions in exudate levels occurred in two of seven people with mild exudate at baseline, six of seven with moderate exudation and six of six with severe exudation.
While the study was small and limited by lack of a comparison group, the results are promising. Sharon Bateman, a specialist tissue viability nurse and the study author, commented: “DFUs have a significant impact on a patient’s quality of life and place patients at higher risk for lower limb amputations. The management of DFU patients can place a significant burden on NHS resources. Aside from the clinical benefits seen in the trial, 75% of patients were able to apply Granulox independently, making the prospect of patients managing their DFU independently or with the help of their healthcare team a distinct reality.”
The study, which was presented at the European Wound Management Association conference and published in the British Journal of Nursing, can be read in full here.
