Status:
TERMINATED
Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers
Lead Sponsor:
Bayer
Conditions:
Venous Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Silica Gel Fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue growth and enhanced wound healing for all types of chronic wounds. It is applied as patch and will be hold i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00998673
Start Date
April 1 2009
End Date
June 1 2011
Last Update
July 14 2015
Active Locations (14)
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1
Berlin, Germany, 10827
2
Bochum, Germany, 44791
3
Bonn, Germany, 53105
4
Cologne, Germany, 50937