Diabetic Foot Ulcers Clinical Trial
Official title:
A Phase 1a, Open Label, Single Dose, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Normal Volunteers Given Punch Skin Biopsies
The purpose of the study is to see if FGF-1 is safe when applied topically to the surface of a wound.
Dermal ulcers pose a significant healthcare problem in the United States, ultimately affecting 10-15% of the approximately 20 million patients with diabetes and a similar number of patients with chronic venous insufficiency. Dermal leg and foot ulcers can result from compromised arterial inflow, microvascular perfusion or venous outflow which can lead to amputation unless vascular perfusion is improved. FGF-1 for topical administration offers the possibility of improved microvascular perfusion by promoting the formation of new blood vessels in the wound bed resulting in enhanced development of granulation tissue and accelerated healing. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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