Randomized standard-of-care-controlled trial of a silica gel fibre matrix in the treatment of chronic venous leg ulcers.
BACKGROUND
Chronic venous leg ulcers (CVU) are a common, unresolved medical problem. Silica gel fibre (SGF) is a novel biodegradable inorganic material developed to serve as a carrier substrate for the local release of pharmaceutical agents facilitating tissue repair.


OBJECTIVE
To assess the performance and safety of SGF in subjects with CVU.


METHODS
Open, randomized, standard-of-care-controlled, multi-centre trial. Subjects (ITT 120 patients) received either SGF in addition to standard treatment or standard-of-care treatment (S-o-C) alone. The primary performance variable was the time to healing of the target ulcer until the end of a 12 week treatment period.


RESULTS
SGF was well tolerated. Mean time to healing up to week 12 was 85.62 days for the SGF group (SE ± 1.5) and 79.66 days for the S-o-C group (SE ± 1.77) (p-value = 0.217). There was no statistically relevant difference regarding the incidence of complete healing of the target ulcers by weeks 12 and 24 between the SGF and the S-o-C groups (p-value >0.05).


CONCLUSIONS
SGF is well tolerated and offers a promising perspective as a carrier substrate for the local release of active pharmaceutical agents into the wound site to promote tissue repair.
Department of Dermatology, University of Cologne Kerpener Str. 62, 50937 Cologne, Germany.
Anneke
A
Brown
Department of health service research in dermatology and health care profession, University of Hamburg-Eppendorf, Germany.
Matthias
M
Augustin
Department of Dermatology, Ernst-Moriz-Arndt-University, Greifswald, Germany.
Michael
M
Jünger
Department of Dermatology, University of Göttingen, Germany.
Markus
M
Zutt
Department of Dermatology, University of Essen, Germany.
Joachim
J
Dissemond
Department of Dermatology, University of Bonn, Germany.
Eberhard
E
Rabe
Department of Dermatology, Johann-Wolfgang-Goethe-University of Frankfurt, Germany.
Roland
R
Kaufmann
Dermatological Practice, Hauptstr. 131, Berlin, Germany.
Margrit
M
Simon
Departement of Dermatology, Ruhr-University of Bochum, Germany.
Markus
M
Stücker
Department of Dermatology, University of Regensburg, Germany.
Sigrid
S
Karrer
Department of Dermatology, University of Mannheim, Germany.
Wolfgang
W
Koenen
Dermatological Practice, Paula-Modersohn-Platz 3, Freiburg, Germany.
Wolfgang
W
Vanscheidt
Department of Dermatology, University of Ulm, Germany.
Karin
K
Scharfetter-Kochanek
Department of Dermatology, Hospital Dresden-Friedrichstadt, Germany.
Uwe
U
Wollina
Department of Dermatology, University of Cologne Kerpener Str. 62, 50937 Cologne, Germany, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Germany, Center for Molecular Medicine (CMMC), University of Cologne, Germany.
Thomas
T
Krieg
Department of Dermatology, University of Cologne Kerpener Str. 62, 50937 Cologne, Germany, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Germany, Center for Molecular Medicine (CMMC), University of Cologne, Germany.
Sabine A
SA
Eming
D000368:Aged; D002908:Chronic Disease; D005260:Female; D006801:Humans; D008297:Male; D058428:Silica Gel / Q000627:therapeutic use*; D059039:Standard of Care; D014647:Varicose Ulcer / Q000188:drug therapy*
D058428:Silica Gel
biodegradable matrix; silica gel fibre matrix; venous ulcer