Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers

Launched by BAYER · Oct 19, 2009

Keywords

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Gender

ALL

Eligibility criteria

• 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