Wound healing becomes problematic in diabetic patients due to a decreased cellular response resulting in non-healing wounds. Approximately 10 to 15% of diabetic patients develop non-healing foot ulcers, which can result in amputation.
Integra LifeSciences Holdings Corporation recently has received approval from the FDA for its new product, Integra® Omnigraft™ Dermal Regeneration Matrix, following positive clinical results (Foot Ulcer New Dermal Replacement (FOUNDER) Study).
Omnigraft is a bi-layered wound dressing designed to provide immediate wound closure whilst promoting dermal regeneration. Wound closure is achieved by a silicone top layer, and the bottom layer contains bovine collagen and chondroitin to act as a scaffold for cell migration.
51% of patients treated with Omnigraft had healed ulcers compared to 32% of patients treated with SOC alone after 16 weeks. 62% patients who received only a single Omnigraft application experienced healing of their wound. On average, ulcers treated with Omnigraft healed 5 weeks faster than ulcers treated with SOC alone.
The product's packaging and room temperature storage is designed for ease of handling and application in the outpatient wound care setting. Therefore, this could provide a welcome improved outpatient therapy option for patients with challenging wounds.