Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00998673
Recruitment Status : Terminated
First Posted : October 20, 2009
Last Update Posted : July 14, 2015
Information provided by (Responsible Party):

October 2, 2009
October 20, 2009
July 14, 2015
April 2009
June 2011   (Final data collection date for primary outcome measure)
Time to healing of target ulcer, defined as the treatment period day during the weekly visit at which the surface area of the wound was noted as zero and completely healed [ Time Frame: Week 12 ]
Time to healing of target ulcer, defined as the treatment period day during the weekly visit at which the surface area of the wound was noted as zero and completely healed [ Time Frame: Week 12 / Week 24 ]
Complete list of historical versions of study NCT00998673 on Archive Site
  • Incidence of complete wound healing of target ulcer at 4, 8 and 12 weeks, defined as full epithelialisation of the wound with the absence of drainage [ Time Frame: Week 4/8/12 ]
  • Rate of recurrence of wound at end of follow-up period of 3 months [ Time Frame: Week 24 ]
  • Size (cm2, measured by Visitrak Wound Measurement System) of target ulcer (Absolute size measured once per week and change between assessments at weeks 0, 4, 8, and 12) [ Time Frame: Week 12/24 ]
Same as current
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Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers
Randomized Standard-of-Care-Controlled Trial of a Silica Gel Fiber (SGF) Wound Dressing in the Treatment of Chronic Venous Leg Ulcers
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 in place by a secondary dressing for maintaining the moist wound environment. The study is aimed to demonstrate superiority over a standard wound treatment for chronic venous leg ulcers. The primary efficacy variable is time to healing.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Venous Ulcer
  • Device: Silica Gel Fiber
    Silica Gel Fiber (SGF) applications as required
  • Device: Standard-of-Care
    Standard-of-Care with dressing changes twice per week using Mepitel and Mepilex wound dressings
  • Experimental: Arm 1
    Intervention: Device: Silica Gel Fiber
  • Arm 2
    Intervention: Device: Standard-of-Care
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Bayer Study Director Bayer
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP