Avita Medical Ltd. has initiated a multicenter randomized control study on the use of ReCell® Spray-On Skin® in the treatment of venous leg ulcers. Up to five European centres from countries including the United Kingdom, Germany, France and Denmark will participate in the study.
Lower limb ulcers (LLUs), which include venous leg ulcers and diabetic foot ulcers, are a major healthcare problem in developed countries due to their prevalence, high cost of treatment and significant impact on patient quality of life. LLUs afflict nearly 1.5% of the general population in OECD countries and up to 3% over the age of 70 years. The expense of treating LLUs imposes a major financial burden on healthcare systems. In the US alone some 6.5 million people suffer from LLUs with associated treatment costs estimated in excess of US$25 billion pa with similar prevalence and expense documented in the UK, Germany and France. The costs to patients include associated morbidity, pain, lack of mobility and lost work days and wages.
In preliminary open-label studies ReCell was used at four European centres to treat approximately 80 patients suffering from venous leg ulcers and diabetic foot ulcers. Across study centres patients’ average age was approximately 70 years, wounds were open an average of approximately 13 months and averaged approximately 21 cm2 in size.
Results of these preliminary studies have been encouraging. Over 70% of patients showed complete healing of the wound within 7-12 weeks following a single treatment with ReCell. With the current standard of care treatment it would be expected that approximately 43% of these wounds would have achieved closure during this period, thus ReCell appears to yield a highly significant positive effect on wound healing. Pain, a critical indicator of quality of life, was reported as being significantly reduced or eliminated within 72 hours following the ReCell treatment.
These data have been presented at congresses and have been submitted as separate papers for publication in peer-reviewed journals.
Given the positive results achieved in preliminary studies, Avita has initiated a randomised control study with leading clinicians at up to 5 European centres. Up to 80 patients will be enrolled in the study. Study protocols have been submitted for approval by the relevant ethics review boards at each centre. It is anticipated that enrolment in the study will commence during the 1st quarter of 2013.