Aim: The aim of this multi-centre observational evaluation was to assess the percentage reduction in wound area of non-healing diabetic foot ulcers (DFUs), treated with Granulox haemoglobin spray over a 4-week period. Secondary outcome parameters--for example, adverse events, patient acceptability and ease of use--were also recorded.
Method: After a run-in-period (2 weeks for existing patients and 4 weeks for new patients) to determine if the wounds were non-healing despite receiving local best practice, patients whose foot ulcers had decreased in size by < 20% were then entered into the evaluation. A sample of 17 patients (4 females and 13 males), comprising 4 with type 1 and 13 with type 2 diabetes, with a total of 20 DFUs, met the inclusion criteria. These data were collected from six sites across the UK.
Results: There was an overall positive reduction in size in 15 of the wounds, equating to a mean reduction of 53.8% (standard deviation (SD): 26.6; range: 11.9-100%). One participant, with two ulcers, had to be withdrawn due to infection. All clinicians and participants found the product easy to use.
Conclusion: The addition of a topical oxygenation therapy in this cohort of non-healing DFUs showed reduction in wound surface area and progression to healing. The product was also found to be acceptable and very easy to use by both participants and clinicians.
Keywords: Diabetic foot ulcer; Haemoglobin; Hypoxia; Non-healing wounds; Topical oxygen therapy; Wound healing.