Jan 11

FDA Approves New Device for Diabetic Foot Ulcers

According to Centers for Disease Control and Prevention, there are around 29 million US patients who are diagnosed with diabetes – the risk of diabetic foot ulcer is now extremely dangerous. However, a new device was created that could save many people’s lives. Such chronic diabetic foot ulcers are linked with the bone and tissue infections that result for about 50,000 cases of amputations every year.

Few days ago, the UD Food and Drug Administration or FDA has approved the (Integra Omnigraft Dermal Regeneration Matrix) or simply called as Omnigraft to cure individual who have diabetic foot ulcers. Basically, the device was made out of silicone, shark cartilage and cow collagen, which is an advanced skin-substitution three-dimensional porous matrix that is crafted to present fast closure of the wound as well as lifetime regeneration of the dermis. In addition, it is situated in direct contact along with the removed wound and plays its role as a scaffold for the migration of cell, enabling for regeneration of the derma layer of the skin of the patient.

Furthermore, the approval for the medication of some diabetic foot ulcers last for more than 6 weeks, which do not include exposure of the joint capsule, bone, tendon, in relation with the basic care of diabetic ulcer. On the contrary, the FDA recently certified the item in few years ago for the medication of life-threatening burn injuries by the time skin of the patients is not available for a graft back on 2002 for usage in reconstructive surgery especially, for burn scars under the same conditions.

The approval is sourced on a 16-week randomized, multicenter, controlled, group of clinical trial called as the Foot Ulcer New Dermal Replacement or also known as FOUNDER Study. It was conducted beneath an investigational tool in that Omnigraft was placed to standard diabetic foot ulcers that involve the bandaging and cleaning of the wound as well as the off-loading of the affected foot.

All the results were made public on November and demonstrated that out of 154 patients assigned to receive also Omnigraft against the 153 who receive standard of care. The device generated healing in 51% against 32% of ulcers later than 16 weeks, together with 59% improvements on the occurrence of complete would closure with the use of device compared to the normal care. Adverse scenarios in the test involved increased pain, infections, nausea, swelling as well as new deteriorating ulcers.

The United States Food and Drug Administration stresses out that the Omnigraft must not be utilized in patients that has allergies to chondroitin or cartilage coming from any source as well as to bovine collagen. It must not also be utilized on infected wounds. The investigators of FOUNDERS presumed that for the certain the medication of chronic diabetic foot ulcers, Omnigraft really lessen the period to complete the closure of wound, enhanced components of quality of life of an individual, increased the number of wound closure and had a lesser adverse case compared to the normal care medication. Thus, the device could extremely improve the medication of non-healing such illness.
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