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A type of “artificial skin” – a biotechnological dressing called Omnigraft – has been approved in the US for the treatment of foot wounds and ulcers in patients with type 2 diabetes, according to Medical Xpress.
Omnigraft, also known as the dermal matrix, consists of silicone, bovine collagen and shark cartilage. When placed on a wound, it provides an environment conducive to the regeneration of the skin and other tissues, thus accelerating the healing process.
The US Food and Drug Administration (FDA) has approved Omnigraft to treat those diabetic foot patients whose wounds have not healed within six weeks and have not exposed a bone, joint capsule, or tendon.
This registration was based on the results of clinical trials conducted in patients with diabetic foot syndrome where Omnigraft was used in conjunction with standard foot ulcer cleansing and care. It turned out that 51 percent. In patients using Omnigraft, the wounds healed within 16 weeks, while in the group who received only standard therapy, the percentage was 32%.
The adverse effects of the dressing observed in patients included: wound infections, increased pain, the appearance of swelling, nausea, as well as deterioration of the wound condition or the appearance of new ulcerations on the foot. The manufacturer of the Omnigrapht states that it should not be used in patients allergic to any component of the dressing, as well as infected wounds.
This dressing was first approved by the FDA in 1996 for the treatment of life-threatening burns to a body where a patient’s skin cannot be transplanted. In 2002, the indications were extended to people who undergo reconstructive surgeries due to burn scars.
Diabetic foot syndrome is a serious complication of diabetes characterized by difficult-to-heal wounds. According to world and Polish statistics, it is the most common cause of leg amputation in adults. Many factors contribute to the formation of hard-to-heal wounds and ulcers on the feet of diabetics, including peripheral neuropathy, i.e. damage to peripheral nerves, due to which patients do not feel any injuries or damage to the skin on the foot, bone deformities and atherosclerosis, which impairs the blood supply to the foot and hinders repair processes.
According to William Maisel of the FDA, thanks to the registration of the Omnigrapht for the treatment of diabetic foot, more patients with this complication will be able to avoid mutilating amputations and return to full activity.