FDA approval for new diabetic wound dressing.

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.

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Epistem validated in vivo diabetic wound healing model

Epistem validated in vivo diabetic wound healing model showing delayed wound healing (wound closure and re-epithelisation) and a decreased inflammatory response.

Other wound healing in vivo models include normal wound healing, LPS-induced inflammation healing and human skin engraft healing models.

In vitro wound healing assays are also available to assess cell proliferation/migration, wound closure and angiogenesis.

Wound healing review: Shaw, T. J. and P. Martin (2009). “Wound repair at a glance.” J Cell Sci 122(Pt 18): 3209-3213

Diabetic wound healing review: Brem, H. and M. Tomic-Canic (2007). “Cellular and molecular basis of wound healing in diabetes.” J Clin Invest 117(5): 1219-1222.

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