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Phase 2Not yet recruiting

Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU) (H2H)

A Multicenter, Prospective, Randomized, Placebo and Non-Surgical Standard of Care (NSSOC) Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to NSSOC in Participants With Venous Leg Ulcers (VLU)

Sponsor
MediWound Ltd (Industry)
Enrolment
45 planned
Conditions
Venus Leg Ulcers
Interventions
EscharEx (EX-03); Placebo (Gel vehicle); Non-surgical standard of care (NSSOC)
Ages
adults, older adults
Registry
NCT06690177, CTIS2026-526070-16-00

Full record on ClinicalTrials.gov

From the registry

The objectives of this study are: * To evaluate the safety of EscharEx and its placebo Gel Vehicle compared to non-surgical standard of care (NSSOC) * To assess the efficacy of EscharEx (EX-03 5% formulation) compared to placebo control and compared to NSSOC.

Primary outcomes

  • Incidence (number of patients) of systemic and local adverse events (AEs) throughout the trial
  • Number of patients with Clinically significant changes in vital signs during the Daily Visits Period,
  • Number of patients with Clinically significant changes in clinical laboratory parameters
  • Time to complete wound closure

History

  1. Study completion expected

  2. Primary completion expected

  3. Expected to start

  4. Last registry update

  5. Registered