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):
- Differential gene expression, at the beginning and the 3rd week of treatment. - Percent of granulation of the injury, at first, 3rd and 8th week post-treatment.
Key secondary outcomes:
- Time to reach 75% or more of granulation (days, months). Measuring time: in weeks 3, 8, 12, 16 and 20 post-treatment. - Total closure of the injury (Yes, No). Measuring time: at weeks 12, 16 and 20 post-treatment. - Adverse events (Event number; Type; Frequency: Yes, No; Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events; Duration: hours, days, months; Causal relationship: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death; Treatment indicated: type and dosage of medication, treatment time). Measuring time: in weeks 3, 8, 12, 16 and 20 post-treatment.