Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MTX-001 (human amniotic fluid)
MTX-001 · 1 trial · 2 indications
Evaluated via patient and/or Investigator reported adverse events that occur during the study
Assessed by percentage area reduction of the ulcer surface area from Baseline to Week 4.
| Arm | Type | Description |
|---|---|---|
| MTX-001 | ACTIVE_COMPARATOR | MTX-001 (human amniotic fluid) solution 0.2 mL/sqcm weekly |
| Placebo (0.9% saline) | PLACEBO_COMPARATOR | Matching placebo solution 0.2mL/sqcm weekly |
| Name | Type | Description |
|---|---|---|
| MTX-001 (human amniotic fluid) | BIOLOGICAL | Subcutaneous injection into and/or around wound bed weekly |
Inclusion Criteria: * Patients who voluntarily give written informed consent to participate in study * Males and female patients aged 18 to 75 years inclusive at Screening (date the patient provides written informed consent to participate in study) for Part 1 only * Males and female patients aged 1...