Randomized standard-of-care-controlled trial of a silica gel fibre matrix in the treatment of chronic venous leg ulcers

Abstract

Eming SA. Randomized standard-of-care-controlled trial of a silica gel fibre matrix in the treatment of chronic venous leg ulcers. Eur J Dermatol 2014; 24(2): 210-6Background: 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. Objectives: 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). Conclusion: 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.Key words: biodegradable matrix, silica gel fibre matrix, venous ulcer * Registration number and name of trial registry: Study number SGF271-01, ClinicalTrials.gov identifier: NCT00998673. Study title "Randomized standard-of-care-controlled trial of a SGF wound dressing in the treatment of chronic venous leg ulcers". Information of trial protocol:

Preparation of Silica Gel Obtained from Early Cretaceous Sidi Aich Sands (Central Tunisia) and its Potential to Remove Pollutant Dye Anionic from Wastwaters

“…Recent studies have investigated the versatility of this amorphous material in applications including llers [10], coatings [11], electronics [12] optics [13], and pharmaceuticals [14] This work is aimed to promote local georesources (silica sands) for the preparation of silica gel.…”

Sol-Gel-Derived Fibers Based on Amorphous α-Hydroxy-Carboxylate-Modified Titanium(IV) Oxide as a 3-Dimensional Scaffold

“…Apart from organic degradable biopolymers, such as polylactide, polyglycolide, or polycaprolactone, sol-gel-derived biocompatible inorganic fibers are also established. For instance, silica gel fibers, produced by the acidic catalyzed hydrolysis and condensation of tetraethoxysilane [19], represent a well-tolerated wound matrix in the regeneration of chronic venous leg ulcers [32] and, additionally, show anti-inflammatory and anti-fibrotic action in the healing of chronic wounds [33]. Furthermore, they promote cellular migration on their surface structures [34].…”