stop_circleTerminated/Withdrawn

Venous Ulcer

Bayer Identifier:

SGF271-01

ClinicalTrials.gov Identifier:

NCT00998673

EudraCT Number:

Not Available

EU CT Number:

Not Available
Silica gel fiber wound dressing for chronic venous leg ulcers

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - At least one chronic venous leg ulcer fulfilling all of the following criteria:
     -- Size: >/= 5 cm2 and  -- 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
  • - 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

Trial summary

Enrollment Goal
121
Trial Dates
April 2009 - June 2011
Phase
Phase 2
Could I Receive a placebo
No
Products
Silica Gel Fiber
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Köln, 50937, Germany
Terminated
Hamburg, 20246, Germany
Terminated
Dresden, 01067, Germany
Terminated
Essen, 45147, Germany
Terminated
Bonn, 53105, Germany
Terminated
Frankfurt, 60590, Germany
Terminated
Göttingen, 37075, Germany
Terminated
Bochum, 44791, Germany
Terminated
Mannheim, 68163, Germany
Withdrawn
Freiburg, 79104, Germany
Terminated
Greifswald, 17487, Germany
Terminated
Regensburg, 93053, Germany
Withdrawn
Frankfurt, 60311, Germany
Terminated
Ulm, 89081, Germany
Terminated
Berlin, 10827, Germany
Terminated
Freiburg, 79100, Germany

Primary Outcome

  • 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
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Week 4/8/12
    enhanced_encryption
    Safety Issue:
    no
  • Rate of recurrence of wound at end of follow-up period of 3 months
    date_rangeTime Frame:
    Week 24
    enhanced_encryption
    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)
    date_rangeTime Frame:
    Week 12/24
    enhanced_encryption
    Safety Issue:
    no

Trial design

Randomized Standard-of-Care-Controlled Trial of a Silica Gel Fiber (SGF) Wound Dressing in the Treatment of Chronic Venous Leg Ulcers
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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