Efficacy and Safety Study of EscharEx to Treat (Debride) Hard to Heal Wounds

This is an interventional treatment trial for Hard to Heal Wounds Read More

Inclusion Criteria

• Patients, men or women, are between 18 and 90 years of age.
• Patient with venous leg ulcer or diabetic (lower extremity) ulcer or traumatic/post operative wound (determined by medical history and physical examination)
• Wound is not healing for at least 4 weeks
• The necrotic/slough/fibrin non-viable tissue area is at least 50% of wound area (assessed by clinical evaluation)
• Wound surface area is in the range of 5- 200 cm2 in the first stage and 3 - 150cm2 in the second stage.
• Patient understands the nature of the procedure, able to adhere to the protocol regimen, and provides written informed consent prior to any study procedure
• The Wound is classified as a wound involving full skin thickness but not penetrating to cavities or open joint spaces

Exclusion Criteria

• Evidence of active osteomyelitis of target organ,
• Patients with more than one hard to heal wounds wounds which require debridement and with an area greater than or equal to 2cm2,
• Presence of purulent discharge, deep-tissue abscess, cellulitis or tissue damage extending >2 cm around the wound's edge, gangrene or signs of systemic infection,
• Wound size decreased by > 20% after 1 week of standard-of-care-only period (screening period),
• Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by Silver sulfadiazine (SSD) pseudoeschar (e.g. pseudoeschar as a result of SSD treatment),
• Ankle-Brachial Index (ABI) ≤ 0.7 or a significant decrease in the blood flow of the extremity as demonstrated by US doppler.
• Wound has sinus tracts or tunnels extending under healthy tissue,
• Patients undergoing renal or peritoneal dialysis,
• Recent history (less than 4 weeks) of myocardial infarction (MI) or concurrent acute injury or disease that might compromise the patient's welfare,
• Any condition that would preclude safe participation in the study: evidence of significant hematological (severe pre-existing coagulation disorder), cardiovascular, liver or neoplastic disease, or any other immediate life threatening condition,
• Patient is currently receiving, or has received at any time within one month prior to enrollment, any medications or treatments known to affect the wound healing processes; these include: chronic systemic steroid intake with topical skin changes (thin, fragile with multiple hematomas and previous laceration history, immuno-suppressive drugs, radiation therapy and chemotherapy.
• History of allergy or atopic disease or a known sensitivity to pineapples, papaya, bromelain or papain,
• Pregnant women (positive pregnancy test) or nursing mothers,
• Participation in another investigational drug trial within 30 days prior to enrollment or anticipated participation while enrolled in the study,
• Concurrent use of non-approved drugs or alcohol abuse.
• Patients with poor nutritional status (albumin < 2.5g/dl), poor diabetic control (HbA1c > 12%), anemia (hemoglobin<8 g/dL), a leukocyte counts < 4,000// μl or >15000/μl, abnormal liver function (AST, ALT>2 x upper limit of normal range), renal failure (Cr > 3 mg/dl);
• Mentally incapacitated adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc),
• Patients with general skin disorders (Psoriasis, Panniculitis, ect) that might deteriorate as a result of local trauma.
• Patients with skin disorders unrelated to the wound that are presented adjacent to the wound
• Clinical suspicion of skin cancer associated with the wound (e.g, BCC, SCC), which was not ruled out by biopsy Patients with diagnosed Sepsis during screening phase,
• Patients suffering from Idiopathic Pruritus.