NCT06690177Phase 2Not yet recruiting

Clinical Study to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase, Non-surgical Standard of Care, in Patients With Venous Leg Ulcers

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-12-30Estimated

Enrollment · participants45Estimated

Source updated2024-11-15Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Venus Leg Ulcers

Treatments or interventions studied

EscharEx (EX-03)Drug
Placebo (Gel vehicle)Drug

Primary outcomes · main study measures

Read the study measures

measure: Incidence (number of patients) of target wound related AEs throughout the trial; description: The endpoint will assess number of patients, in each arm, with reported local (target wound related) AEs; timeFrame: Throughout the study (week 2- week 15); measure: Number of patients with Clinically significant changes in vital signs during the Daily Visits Period,; description: Number of patients with Clinically significant changes in vital signs; timeFrame: Weeks 2-3 (14 days); measure: Number of patients with Clinically significant changes in clinical laboratory parameters; description: Number of patients with Clinically significant changes in clinical laboratory parameters; timeFrame: Weeks 2-3 (14 days); measure: Time to complete wound closure; description: The outcome will assess time to reaching complete wound closure; timeFrame: Weeks 2-15; measure: Incidence of complete wound closure; description: The outcome will assess number of patients reaching complete wound closure; timeFrame: 2-15 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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