A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
Condition: Venous Leg Ulcer; Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Varicose Ulcer; Foot Ulcer; Leg Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be a multicenter, prospective, open label, one-arm study intended to assess
      the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg
      Ulcers (VLU) and Diabetic Foot Ulcer (DFU). In addition, the pharmacology effect of EX-02
      will be assessed.

      Lower leg ulcer size between 2 cm2 and 80 cm2 (surface area).
    

Detailed description: 
      Up to fifteen (15) adult patients with >50% non-viable tissue (necrotic/ slough/ fibrin) on
      the ulcer will be enrolled from up to 3 sites.

      Each patient will go through the following steps during the trial:

        1. Screening and Inform Consent signing - screening visit duration will be up to 1 week and
           will include: recording demographics, medical history and concomitant medications, vital
           signs, physical examination, clinical laboratory tests, wound photography and
           assessments and pain assessment questionnaires. Wound fluid sampling and 3 mm punch
           biopsy (from the wound edge area) will be taken during screening.

        2. Daily visits period (up to 8 daily site visits within up to 14 days), including an
           additional visit, 48 hrs after last daily visit for wound fluid sampling. During the
           Daily visits period, the patient will arrive daily to site visits. During each visit,
           adverse events (AEs), concomitant medications, vital signs, and pain will be assessed
           and recorded, the wound will be washed, photographed and assessed for wound size and for
           % of nonviable tissue by clinical assessment. During the daily visits period, the
           peri-wound will be well protected with topical barrier (e.g zinc oxide paste). For VLU,
           compression therapy must be used throughout daily visits period.

           The investigator will clinically assess complete debridement, upon achieving a viable
           wound bed after removal of all non-viable tissue, suitable for initiation of the wound
           healing stage.

           Patients will be treated with EX-02 for up to 8 applications (up to 8 visits) or until
           complete debridement is achieved, whichever occurs first. Duration of each application
           will be 24±3 hours. On weekends occurring during the daily visits period the wound will
           be dressed with a non-active dressing (e.g. foam).

           Hydrogels as well as methods of active debridement (either surgical, mechanical,
           biological, enzymatic or other dressings), grafting and V.A.C are not allowed during
           this period and while daily visits are ongoing.

           Fluid samples will be taken from the EX-02 treated wound before the first treatment and
           once the wound has reached complete debridement or daily visits completed, whichever
           occurred first. Punch biopsies from the wound edge will be taken before and at the end
           of the debridement to assess for biofilm.

           Clinical lab tests and physical examination as well as pain assessments and vital signs
           will be performed at the end of daily visits period (once the wound has reached complete
           debridement or daily visits completed, whichever occurred first).

           For patients who achieved complete debridement, wound closure could be considered using
           grafting/autograft procedure.

           After completion of the daily visits period (either if complete debridement was
           achieved, or after 8 daily applications were performed) patients will start the weekly
           follow- up period.

        3. Weekly follow- up period (2 visits in 2 weeks) - the 2 weekly follow up period should be
           performed at the clinical site. During each weekly visit, safety parameters will be
           recorded (AEs, concomitant medications, pain, vital signs), the wound will be washed,
           photographed and assessed for wound size and for % of nonviable tissue.

      For wounds which did not reach complete debridement during the daily visits period, the
      investigator should continue to persue complete debridement using surgical or non- surgical
      debridement tools (SOC), per the investigators discretion.

      Compression therapy must be used throughout this period for VLU patients and as determined by
      investigator to be appropriate for DFU.

      The overall duration of the study for each patient will be approximately 4-5 weeks.
    

Intervention name(s): EscharEx (EX-02 formulation)
Intervention type(s): Drug
Intervention description(s): EscharEx (EX-02 formulation) gel is topically applied on a wound surface of up to 80 cm2 , up to 8 consecutive applications or until a complete debridement is achieved, whichever occurs first.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment