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):

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 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.

Condition or disease Intervention/treatment Phase
Venous Ulcer Device: Silica Gel Fiber Device: Standard-of-Care Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Standard-of-Care-Controlled Trial of a Silica Gel Fiber (SGF) Wound Dressing in the Treatment of Chronic Venous Leg Ulcers
Study Start Date : April 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1 Device: Silica Gel Fiber
Silica Gel Fiber (SGF) applications as required

Arm 2 Device: Standard-of-Care
Standard-of-Care with dressing changes twice per week using Mepitel and Mepilex wound dressings

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Rate of recurrence of wound at end of follow-up period of 3 months [ Time Frame: Week 24 ]
  3. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00998673

Berlin, Germany, 10827
Bochum, Germany, 44791
Bonn, Germany, 53105
Dresden, Germany, 01067
Essen, Germany, 45147
Frankfurt, Germany, 60590
Freiburg, Germany, 79100
Greifswald, Germany, 17487
Göttingen, Germany, 37075
Hamburg, Germany, 20246
Köln, Germany, 50937
Mannheim, Germany, 68163
Regensburg, Germany, 93053
Ulm, Germany, 89081
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00998673     History of Changes
Other Study ID Numbers: SGF271-01
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015

Keywords provided by Bayer:
Silica gel fiber
Chronic venous leg ulcers
Venous ulcer
Stasis ulcer
Varicose ulcer

Additional relevant MeSH terms:
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases