Table of contents
- Trial overview
- Who can participate
- What is being measured
- Trial phase and design
- Study status and size
Trial overview
The available study is titled “NEurotrophins Mimetic compound for the treatment of diabetic foot UlcerS” and is testing UDONITRECTAG for diabetic foot ulcer.[1] It is an interventional trial, which means the researchers assign the treatment rather than only observing what happens.[1]
The brief summary says the study is designed to determine the safety, tolerability, and pharmacokinetic profile of UDONITRECTAG, also called MT8, when added to standard of care versus standard of care alone.[1]
Who can participate
The source data shows that the study population is people with diabetic foot ulcers.[1] No other entry details, such as age limits or other medical rules, are provided in the trial data.[1]
This means the trial is focused on patients who already have this wound condition and are receiving usual care for it.[1]
What is being measured
The main outcome is safety and tolerability, including the nature, frequency, severity, and timing of adverse events.[1] Adverse events include skin irritation, blood-related problems, liver-related problems, and kidney-related problems.[1]
The study also measures clinical laboratory results during and after UDONITRECTAG administration.[1] Another key endpoint is pharmacokinetics, which means how the treatment behaves in the body over time.[1]
Trial phase and design
The trial is in Phase 1/2, an early stage of research that usually looks first at safety and then at early signs of benefit.[1] The study is interventional, so the researchers are actively testing UDONITRECTAG rather than only watching routine care.[1]
The intervention is listed as drug use by local use, which means it is applied at the site being treated rather than given as a general treatment in the body.[1]
Study status and size
The trial status is Authorised.[1] The planned enrollment is 24 participants, so this is a small early study.[1]
Because the study is small and early, its main purpose is to learn whether the treatment can be used safely in this patient group and how the body handles it.[1]
