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Silica Gel Fiber Wound Dressing for Chronic Venous Leg Ulcers

This study has been terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00998673
First received: October 2, 2009
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Venous Ulcer
 Device: Silica Gel Fiber
Device: Standard-of-Care
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Rate of recurrence of wound at end of follow-up period of 3 months [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: April 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998673

Locations
Germany
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Innovation GmbH
ClinicalTrials.gov Identifier: NCT00998673     History of Changes
Other Study ID Numbers: SGF271-01
Study First Received: October 2, 2009
Last Updated: July 16, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on May 21, 2013