Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
EGF plasmatic levels (ELISA tecnhique). Measuring times: at the screening, 0 h (before first injection) and 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 12 h and 24 h after each application of 75 or 225 µg. Severe adverse events (Appearance of severe adverse events (Yes, No). Measuring time: at each administration during the 8 weeks of treatment.
Key secondary outcomes:
Complete closure of the lesion (defined by the epithelization and total closure of the lesion without secretion or dressing application). Measuring time: before treatment, and weeks 4, 8, 12, 16 and 20. One-hundred percent of soft granulation tissue. Measuring time: before treatment, and weeks 4, 8, 12, 16 and 20. Clinical adverse events (AE). Measuring time: at each administration during 8 weeks of treatment -Appearance of AE (Yes, No) -Type of AE (name of the AE) -Duration (time between beginning and end of the event), -Intensity of AE (mild, moderate, severe) -Relation of causality (remote, possible, probable, very probable) -Result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation). Anti-EGF antibodies (by ELISA technique. Patients that develop antibodies (Yes, No)). Measuring time: before treatment, week 8 and week 20.