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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMediWound Ltd

About this trial

The main objective of this study is:

To assess the safety of EscharEx (EX-03 5% formulation) compared to placebo control and compared to Collagenase (NSSOC) in patients with VLU.

Eligibility criteria

Qualifiers

Men or women, older than 18 years of age,

Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency),

Wound is present for at least 4 weeks but no longer than 1 year,

The necrotic/slough/fibrin non-viable tissue area is at least 50% of the wound area (assessed by clinical evaluation),

Disqualifiers

None

Trial design

Treatments tested in this trial

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

Treatment groups

45 Participants
are divided into 3 treatment groups

Sponsors and collaborators