A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers

Overview

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).

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.

Conditions

Interventions

Eligibility

Locations (3)

Outcomes