The three most common types of chronic wounds are diabetic foot ulcers (DFU), venous leg ulcers and pressure ulcers. Current estimates put the total annual incidence of chronic wounds at almost 9 million worldwide, of which 3 million are in the US. DFU precede 85% of non-traumatic lower extremity amputations and they are responsible for most of the roughly 80,000 amputations of toes, feet and lower legs in the U.S. diabetic population each year. Early detection and appropriate treatment of these ulcers may prevent up to 85 percent of amputations. The global DFU market is estimated to grow to $2.275B in 2017, with double-digit growth of 10% per year. This growth is being driven by an ageing population and the rise in the incidence of diabetes.
Curasite™, a hydrogel-based product, has been shown to be efficacious in the treatment of both diabetic foot ulcers and pressure ulcers. A Phase I study in human subjects showed accelerated healing of chronic, non-responding wounds with the use of Curasite™. After treatment with Curasite™ for three weeks, over 27% of patients achieved complete wound closure, and of the patients followed after treatment 45% achieved full closure at 6 weeks and 100% had complete wound closure at 12 weeks.
A double-blind, randomized Phase II clinical trial that compared Curasite™ to an active-control in 82 patients suffering from non-healing DFU was conducted. Patients who received Curasite™ for four weeks attained an average of over 50% wound closure and, after a 12 week course of treatment, patients receiving Curasite™ therapy experienced nearly 90% wound closure.
These exciting results have recently led to FDA approval of Curasite™ as a medical device (510(k)).