Study to Evaluate Polyheal-1 in Treatment of Recalcitrant Wounds

• The patient is 18 years of age and older.
• The patient has at least one recalcitrant wound (venous insufficiency, post- operative and post-traumatic chronic wounds with different etiology including those with open wounds) refractive to healing at least 4 weeks prior to treatment
• Patients defined as grade 4 or below on the granulometer including wounds with exposed bone or tendon.
• Patients will be eligible to participate in the study if their target lesion area of the edges is larger than 15cm2 and smaller than 200 cm2 at baseline in the group A of wounds caused by venous insufficiency or larger than 2cm2 and smaller than 200 cm2 at baseline in the group B of post-operative and post- traumatic chronic wounds with exposed bone, tendon and/or ligaments.
• The patient is expected to be available for the 12 weeks study.

Exclusion Criteria:

• Clinically significant arterial vascular disease with ABI index \<0.45 if the peripheral pulse is not palpable.
• Wound has necrotic tissue which covers more than 50% of the wound area.
• Neuropathic wounds of diabetic origin.
• Roentgenic (X-ray) evidence of osteomyelitis in target wound in case that the bone is detectable by insertion of wire.
• Diabetic patients with HbA1c >11%
• Presence of a systemic infection or significant local infection such as cellulites, purulent drainage, gangrene, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement.
• Previous history of any illness or condition that may impair wound healing, immune deficiency or connective tissue disease (e.g., SLE, AIDS), neurological disease (e.g., multiple sclerosis), dialysis due to renal disease and active hepatic disease.
• Patient is receiving, or has received within one month prior to Visit 1 any treatment known to impair wound healing, including but not limited to: corticosteroids, immuno- suppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
• Patient has a history of alcohol or drug abuse within the last two years.
• Presence or suspicion of any malignancy.
• Treatment with a dressing containing growth factors or other biological dressings within 15 days, prior to the screening visit.
• Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
• Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.