A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMediWound Ltd

About this trial

The main objective of this study is:

To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (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 adherent necrotic/thick slough/fibrin non-viable tissue area, assessed following wound cleansing with wet gauze and either sterile saline or water and mild soap, at least 50% of the wound area (assessed by clinical evaluation),

Disqualifiers

Wound size that has decreased by > 20% after 7 (+3/-1) days of the screening period,

Patients with more than one leg ulcer, on the leg of the target wound, with an area greater than or equal to 2 cm2, that are between 2cm and 5cm away from the edge of the target wound,

Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,

Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending >2 cm around the wound's edge,

Trial design

Treatments tested in this trial

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

Treatment groups

216 Participants
are divided into 2 treatment groups

Sponsors and collaborators