Diabetic Foot Ulcer
Conditions
Brief summary
Safety and tolerability: I. Nature, frequency, severity, and timing of adverse events including skin irritation, haematological, hepatic, and renal events, II. Clinical laboratory results during and following udonitrectag administration, III. Pharmacokinetics
Detailed description
Efficacy: percentage (number) of patients with ulcer achieving an area reduction of at least 50% from baseline during 6-week treatment. The percentage change area is defined as ((Area0 - Areat)/Area0)*100.
Interventions
DRUGUdonitrectag
Sponsors
Mimetech S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability: I. Nature, frequency, severity, and timing of adverse events including skin irritation, haematological, hepatic, and renal events, II. Clinical laboratory results during and following udonitrectag administration, III. Pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: percentage (number) of patients with ulcer achieving an area reduction of at least 50% from baseline during 6-week treatment. The percentage change area is defined as ((Area0 - Areat)/Area0)*100. | — |
Countries
Italy
Outcome results
None listed