The purpose of this compassionate use protocol is to evaluate the effectiveness of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) injected subcutaneously into the perilesional area in this chronic, non-healing ulcer. Clinical studies have predicated the safety and effectiveness of GM-CSF, and have shown its ability to cause human skin cell growth and speed healing in leg ulcers, pressure ulcers, and wounds in the skin of leprosy patients. GM-CSF has been shown to enhance several cellular functions known to be important in wound healing. GM-CSF stimulates proliferation and activation of neutrophils, monocytes, lymphocytes, keratinocytes, Langerhams' cells, and endothelial cells. GM-CSF has been shown to be superior to TNF and platelet-derived growth factor in stimulating accumulation of macrophages in wounds and production of a smooth muscle actin in fibroblasts, important for gramulation tissue formation. The activity of GM-CSF on cells involved in wound healing has led to reports of the use of GM-CSF in the treatment of ulcers of several etiologies, including diabetic foot ulcers venous stasis ulcers, and pyoderma gangrenosum.
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