With the demographics of both increasing world-wide, chronic ulcers represent a growing clinical and economic problem. The incidence of diabetes is now considered to be of world epidemic proportions, affecting 4-8% of the population in developed countries. The number of people with diabetes is expected to reach 5 million in the UK, 63 million in USA and 360-552 million world-wide by 2025-2030. This representing an 85% increase since 2003.

The highest proportion (47%) of patients hospitalised for the management of diabetes are admitted with active foot disease or develop a foot ulcer during their stay. It is estimated that over 52 million diabetic patients presented with foot ulcers in 2012 world-wide and approximately 61,000 people with diabetes have foot ulcers at any given time in the UK.

Best clinical practice (i.e. wound debridement and application of antibiotics) is effective in less than 40% of cases. The recurrence of apparently healed ulcers is high (70% after 5 years); the development of new ulcers is common and lower limb amputation is eventually required in 10-15% of patients with chronic ulcers, this accounting for over 80% of all lower leg amputations. The overall success rate of so-called "advanced" wound healing therapies is low, typically providing less than a 20% added benefit over best practice protocols, whilst their cost is disproportionately high.