Trial Condition(s):

Venous Ulcer

Silica gel fiber wound dressing for chronic venous leg ulcers

Bayer Identifier:

SGF271-01

ClinicalTrials.gov Identifier:

NCT00998673

EudraCT Number:

Not Available

Terminated/Withdrawn

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.

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

Trial Summary

Enrollment Goal
121
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Silica Gel Fiber
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Köln, Germany, 50937

Status
Terminated
 
Locations

Investigative Site

Hamburg, Germany, 20246

Status
Terminated
 
Locations

Investigative Site

Dresden, Germany, 01067

Status
Terminated
 
Locations

Investigative Site

Essen, Germany, 45147

Status
Terminated
 
Locations

Investigative Site

Bonn, Germany, 53105

Status
Terminated
 
Locations

Investigative Site

Frankfurt, Germany, 60590

Status
Terminated
 
Locations

Investigative Site

Göttingen, Germany, 37075

Status
Terminated
 
Locations

Investigative Site

Bochum, Germany, 44791

Status
Terminated
 
Locations

Investigative Site

Mannheim, Germany, 68163

Status
Terminated
 
Locations

Investigative Site

Greifswald, Germany, 17487

Status
Terminated
 
Locations

Investigative Site

Regensburg, Germany, 93053

Status
Terminated
 
Locations

Investigative Site

Ulm, Germany, 89081

Status
Terminated
 
Locations

Investigative Site

Berlin, Germany, 10827

Status
Terminated
 
Locations

Investigative Site

Freiburg, Germany, 79100

Status
Terminated
 

Trial Design