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leading cause of non-traumatic lower extremity amputations in the United States, and approximately 14-24% of patients with diabetes who develop a foot ulcer will require an amputation. Foot ulceration precedes 85% of diabetes-related amputations. The gold standard for Diabetic Foot Ulcer treatment includes debridement of the wound, management of any infection, revascularization procedures when indicated, and off-loading of the ulcer. Currently, the market is mainly dominated by off-label generic drugs such as analgesics and anti-infectives, around 78% of the current market is captured by these two classes of drugs.  There is only one drug, Regranex (Becaplermin), which the FDA has approved. Regranex gel uses a Platelet-derived growth factor (PDGF) for the Diabetic Neuropathic Ulcer treatment formulated to act as a first-line treatment following effective ulcer care. The US FDA had approved the biologics license application of Becaplermin (OMJ Pharmaceuticals, Inc

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