Terminated/Withdrawn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

Inclusion Criteria
- 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
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

Trial summary

Enrollment Goal

121

Trial Dates

April 2009 - June 2011

Phase

Phase 2

Could I Receive a placebo

Products

Silica Gel Fiber

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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
Time Frame:
Week 12
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
Time Frame:
Week 4/8/12
Safety Issue:
no
Rate of recurrence of wound at end of follow-up period of 3 months
Time Frame:
Week 24
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
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

Additional Information

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