Tissue Repair Technologies Limited

Medical need

Non-healing (chronic) skin ulcers are most frequently encountered in the elderly and in patients with diabetes. 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.

Foot ulcer is a major complication of diabetes, occurring in 10-25% of all patients with diabetes. Between 10-15% of foot ulcers result in amputation of a foot or leg. 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.

Current treatments for non-healing diabetic foot ulcers are largely ineffective. 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.

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