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) in December 1997.