Efficacy and Safety Study of EscharEx to Treat (Debride) Hard to Heal Wounds
Condition: Hard to Heal Wounds; Venous Leg Ulcers; Diabetic Lower Extremity Ulcers; Traumatic/ Post Operative Wounds
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer; Wounds and Injuries; Surgical Wound
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to assess the safety and the efficacy of EscharEx in
      preparing the wound's bed in patients with hard to heal venous leg ulcers, diabetic lower
      extremity ulcers and traumatic/post operative wounds.

      This study will be a multi-center, assessor blinded, randomized, controlled study intended to
      demonstrate superiority of EscharEx debriding treatment over the Gel Vehicle control
      treatment in patients with hard to heal wounds.

      72 + 24 adults with >50% necrotic/slough/fibrin non-viable tissue on a hard to heal wound
      (venous leg ulcer, diabetic lower extremity ulcer or traumatic/ post operative wound) between
      5 cm2 and 200 cm2 (surface area in stage 1) or 3 cm2 - 150 cm2 (in stage 2), will be enrolled
      into the study.

      Patients will undergo a 1 week screening period (2 visits) which will include: record of
      demographics, medical history and concomitant medications, vital signs, physical examination,
      clinical laboratory tests, wound photography and assessments and questionnaires (wound status
      and quality of life). During this period wounds will be treated by standard treatment per the
      decision of the physician. During this screening period, subjects whose study wound size
      (surface area) decreases by more than 20 percent will be excluded. Following completion of
      the screening process, eligible patients will be randomized to either EscharEx or Gel vehicle
      debridement treatments. In stage 1 (72 patients): Treatment will be performed for up to 10
      applications or until complete debridement is achieved, whichever occurs first. In stage 2
      (24 patients): Treatment will be performed for up to 8 applications or until complete
      debridement is achieved, whichever occurs first. Following each application the wound will be
      washed, photographed and assessed for wound size, removal of nonviable tissue and change in
      granulation tissue (by digital planimetry software), wound status, and safety parameters.
      Subsequent to each debridement treatment the wound will be dressed with moist-to-moist saline
      gauze (except when successive 24h or 48h treatments are performed, in the second stage).
      Following completion of the debridement treatment period, patients will be treated according
      to standard procedures and evaluated (wound assessments) once a week until complete wound
      closure for up to 12 weeks from last application (up to 12 visits). Only during the first
      stage of the study, for patients who achieved wound closure, additional 3 monthly (3 visits)
      follow- up visits of wound closure recurrence will be conducted. Quality of life (QoL) will
      be evaluated at the last follow-up visit - 3 months post wound closure follow-up period. For
      patients who didn't achieve wound closure only the 3 months FU visit will be conducted. For
      patients enrolled at the second stage, if wound closure was achieved at the 12 weeks
      follow-up, additional visit will be performed 2 weeks later to confirm wound closure.
    


Intervention name(s): EscharEx; Gel Vehicle
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment