A novel treatment involving oxygen therapy has shown promise in a small study of UK patients with non-healing diabetic foot ulceration.
The study showed diabetic foot ulcers treated with Granulox demonstrated significantly better and more rapid wound closure than standard care.
“Diabetic foot ulcers have a significant impact on a patient’s quality of life and place patients at higher risk for lower limb amputations”
Granulox is topical haemoglobin spray treatment for chronic wounds, which was launched in England, Wales and Scotland in 2014.
The active haemoglobin is intended to improve the oxygen supply to the wound by aiding diffusion of oxygen into its base and, as a result, accelerate healing.
The study – the UK’s largest to date on the technology – was conducted by South Tees NHS Hospitals Foundation.
It included 20 adult patients with non-healing diabetic foot ulcers located beneath the ankle. Of the 20 patients in the study, seven had type 1 diabetes and the remaining 13 had type 2.
After four weeks, all trial patients reported a reduction in wound surface area, elimination of slough and an improvement in exudate levels.
A quarter of patients reported a 100% reduction in wound area. The average wound size reduction was 62.3%, said the researchers.
They added that even wounds that had been present for 12 months or more reduced by an average of 24% within the four weeks of the trial.
During the treatment with Granulox, the researchers found all patients in the trial – who previously had a wound bed slough between 10%-100% – were slough-free, with no debridement required.
In addition, there was a significant reduction in exudate levels across all patients – a 29% reduction in wounds with mild exudate, a 86% reduction in moderate exuding wounds and a complete resolution of all six patients with severe exuding wounds.
Both the patient and clinician experience of Granulox was positive, with the treatment’s easy-to-use spray functionality hailed as a key product benefit, added the technology’s developer infirst Healthcare.
Study author Sharon Bateman, a specialist tissue viability nurse at South Tees, noted that foot ulcers put patients at a higher risk of lower limb amputations as well as placing a significant burden on NHS resources.
She suggested the new oxygen therapy had the potential to boost self-management of foot ulcers among diabetes patients.
“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 diabetic foot ulcer independently or with the help of their healthcare team a distinct reality,” she said.