Venous Ulcer

Inclusion Criteria

- At least one chronic venous leg ulcer fulfilling all of the following criteria:
 -- Size: >/= 5 cm2 and </= 40 cm2 (measured by Visitrak Wound Measurement System)
 -- Duration: >/= 3 month < 5 years
 -- Location: Between and including knee and ankle
 -- Depth: Involving dermis, with no exposed muscle, tendon or bone. Characterized by a viable wound bed with granulation tissue
 -- The etiology of the ulcer as "venous" is proven by Duplex or Doppler sonography and with ankle/brachial arterial Doppler pressure index > 0.8 (exclusion criterion for peripheral arterial disease) and < 1.3 (exclusion criterion for medial sclerosis), or with a laser Doppler value > 40
 - Treatment with active wound care agents paused for 14 days before start of study treatment

Exclusion Criteria

- Only ulcers of other than venous etiology, e.g., diabetic ulcers or ulcers resulting from electrical, chemical, or radiation insult, after contact eczema, etc.
 - History of radiotherapy to the target ulcer site
 - Signs of infection as defined by rubor, dolor, calor, tumor, functio laesa. Fever (38°C sublingual, rectal, or ear), rigors, or leukocytosis will be considered as signs of infection in the context of the general appearance of the wound
 - Target ulcer lacking any sign of granulation tissue (bradytrophic wound bed)
 - Presence of necrotic tissue
 - Presence of fistula
 - History of connective tissue disease, e.g., systemic lupus erythematodes, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
 - Uncontrolled congestive heart failure
 - Malnutrition (albumin < 2.5 g/dl; to be measured if clinical signs of malnutrition are being observed)
 - Uncontrolled diabetes (HbA1c > 8 %)
 - Previous organ transplantation
 - Active malignant disease
 - Severe rheumatoid arthritis
 - Undergoing haemodialysis
 - Active sickle cell disease
 - Patients who are immunocompromised for reasons such as therapy with corticosteroids, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes
 - Pregnant or nursing women
 - Woman of childbearing potential who are not practicing acceptable methods of birth control during the investigation period
 - Known allergy to any of the devices' constituents