One Australian loses a limb every 3 h as a direct consequence of diabetes related foot disease, usually due to an infected diabetic foot ulcer (DFU) [1
]. That amounts to around 8000 lower extremity amputations (LEA) undertaken in Australia each year [3
]. In Western Australia (WA) alone, more than 200 major (above the ankle) LEA are performed annually and recurrent minor (below the ankle) amputations in patients with Type 2 diabetes (T2DM) are increasing by about 3.5% per annum [5
]. There has been a 30% increase in diabetes-related amputations, largely related to increasing diabetes prevalence [6
] in Australia over the past decade and 8% of diabetes-related deaths are attributable to foot complications [1
]. These poor outcomes have persisted despite increasing awareness of the medical, economic and social burden of diabetic foot complications [8
]. The economic costs and mortality rates exceed that of many common cancers; the 5-year mortality rate of patients with diabetic foot infections is ~ 50% [9
]. The estimated economic burden in Australia may exceed $1.5 billion, with DFU accounting for 33% of diabetes related costs [13
]. Poor outcomes associated with DFU are disproportionately high in the Australian Indigenous population [14
]. A recently published systematic review has found that Aboriginal and Torres Strait Islander Australians are 3–6 times more likely to experience a diabetes related foot complication than non-Aboriginal Australians [15
]. Therefore there is an urgent need to test interventions to improve healing time, reduce recurrent ulceration and the incidence of LEA in patients with DFU whilst optimising function and quality of life.
In addition to in-patient services required when the DFU becomes limb or life threatening, most of the morbidity and economic burden of DFU is carried by public sector outpatient services. Wound healing time is a key cost driver and influences the overall cost-benefit analysis for any DFU intervention [16
]. It is estimated that the mean healing time for a DFU managed without amputation is 6 months, rising to 12 months if an amputation is required [17
]. The outpatient component of management accounts for 71% of the total costs associated with DFU and suggests that reductions in the time to healing are likely to have major benefits for direct costs, particularly related to home nursing visits, dressings and outpatient appointments.
We hypothesise that the use of ‘spray-on’ autologous skin grafting (ReCell®; Avita Medical) in DFU will decrease healing time and thereby reduce overall cost of treatment. Autologous ‘spray on’ skin aids epithelial regeneration and has been used successfully in the treatment of scars and burns and other ulcers [19
], particularly when traditional split skin grafting is not feasible. Although it has shown some early promise in a small case series of 4 ft ulcers [20
] and for other chronic ulcers [19
], no randomised trial of this product has been completed or is currently planned. The aim of this study is to assess the potential benefit of spray-on skin as a superior, and cost-effective, management strategy for DFU.