Skip to main content
SpringerLink
Log in

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

  • Therapy
  • Published:
European Journal of Dermatology Aims and scope

An Erratum to this article was published on 01 May 2014

This article has been updated

Abstract

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.

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

Change history

References

  1. Meyer V, Kerk N, Meyer S, George T. Differential diagnosis and therapy of leg ulcers. J Dtsch Dermatol Ges 2011; 9: 1035–1053.

    PubMed  Google Scholar 

  2. Rabe E, Pannier-Fischer F, Bromen K, Schuldt K, Stang A, Poncar Ch A. Bonn Vein Study by the German Society of Phlebology. Phlebologie 2003; 32: 1–14.

    Google Scholar 

  3. Diener H, Herberger K, Augustin M, Debus ES. Chronical wound management. Phlebologie 2011; 40: 303–316.

    Google Scholar 

  4. Chaby G, Senet P, Vaneau M, et al. Dressings for acute and chronic wounds: a systematic review. Arch Dermatol 2007; 143: 1297–1304.

    Article  PubMed  Google Scholar 

  5. Metcalfe AD, Ferguson MWJ. Tissue engineering of replacement skin: the crossroads of biomaterials, wound healing, embryonic development, stem cells and regeneration. J R Soc Interface 2007; 4: 413–437.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  6. Lutolf MP, Hubbell JA. Synthetic biomaterials as instructive extracellular microenvironments for morphogenesis in tissue engineering. Nat Biotechnol 2005; 23: 47–55.

    Article  CAS  PubMed  Google Scholar 

  7. Martino MM, Tortelli F, Mochizuki M. Engineering the growth factor microenvironment with fibronectin domains to promote wound and bone tissue healing. Sci Transl Med 2011; 3: 100ra89.

    Article  PubMed  Google Scholar 

  8. Grotheer V, Goergens M, Fuchs PC, et al. The performance of an orthosilicic acid-releasing silica gel fibre fleece in wound healing. Biomaterials 2013; 34: 7314–7327.

    Article  CAS  PubMed  Google Scholar 

  9. Ince P, Game FL, Jeffcoate WL. Rate of healing of neuropathic ulcers of the foot in diabetes and its relationship to ulcer duration and ulcer area. Diabetes Care 2007; 30: 660–663.

    Article  PubMed  Google Scholar 

  10. Moffatt CJ, Doherty DC, Smithdale R, Franks PJ. Clinical predictors of leg ulcer healing. Br J Dermatol 2010; 162: 51–58.

    Article  CAS  PubMed  Google Scholar 

  11. Gelfand JM, Hoffstad O, Margolis DJ. Surrogate endpoints for the treatment of venous leg ulcers. J Invest Dermatol 2002; 119: 1420–1425.

    Article  CAS  PubMed  Google Scholar 

  12. Palfreyman SJ, Nelson EA, Lochiel R, Michaels JA. Dressings for healing venous leg ulcers. Cochrane Database Syst Rev 2006: CD001103.

    Google Scholar 

  13. O’Donnell TF Jr., Lau J. A systematic review of randomized controlled trials of wound dressings for chronic venous ulcer. J Vasc Surg 2006; 44: 1118–1125.

    Article  PubMed  Google Scholar 

  14. Steed DL, Donohoe D, Webster MW, Lindsley L. Effect of extensive debridement and treatment on the healing of diabetic foot ulcers. Diabetic Ulcer Study group. J Am Coll Surg. 1996; 183: 61–64.

    CAS  PubMed  Google Scholar 

  15. Doerler M, Reich-Schupke S, Altmeyer P, Stücker M. Impact on wound healing and efficacy of various leg ulcer debridement techniques. J Dtsch Dermatol Ges 2012; 10: 624–632.

    PubMed  Google Scholar 

  16. Margolis DJ, Berlin JA, Strom BL. Risk factors associated with the failure of a venous leg ulcer to heal. Arch Dermatol 1999; 135: 920–926.

    Article  CAS  PubMed  Google Scholar 

  17. Wong IKY, Andriessen A, Charles HE, et al. Randomized controlled trial comparing treatment outcome of two compression bandaging systems and standard care without compression in patients with venous leg ulcers. J Eur Acad Dermatol Venereol 2012; 26: 102–110.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Dermatology, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany

    Anneke Brown, Thomas Krieg & Sabine A. Eming

  2. Department of health service research in dermatology and health care profession, University of Hamburg-Eppendorf, Hamburg, Germany

    Matthias Augustin

  3. Department of Dermatology, Ernst-Moriz-Arndt-University, Greifswald, Germany

    Michael Jünger

  4. Department of Dermatology, University of Göttingen, Göttingen, Germany

    Markus Zutt

  5. Department of Dermatology, University of Essen, Essen, Germany

    Joachim Dissemond

  6. Department of Dermatology, University of Bonn, Bonn, Germany

    Eberhard Rabe

  7. Department of Dermatology, Johann-Wolfgang-Goethe-University of Frankfurt, Frankfurt, Germany

    Roland Kaufmann

  8. Dermatological Practice, Hauptstr. 131, Berlin, Germany

    Margrit Simon

  9. Departement of Dermatology, Ruhr-University of Bochum, Bochum, Germany

    Markus Stücker

  10. Department of Dermatology, University of Regensburg, Regensburg, Germany

    Sigrid Karrer

  11. Department of Dermatology, University of Mannheim, Mannheim, Germany

    Wolfgang Koenen

  12. Dermatological Practice, Paula-Modersohn-Platz 3, Freiburg, Germany

    Wolfgang Vanscheidt

  13. Department of Dermatology, University of Ulm, Ulm, Germany

    Karin Scharfetter-Kochanek

  14. Department of Dermatology, Hospital Dresden-Friedrichstadt, Dresden, Germany

    Uwe Wollina

  15. Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Cologne, Germany

    Thomas Krieg & Sabine A. Eming

  16. Center for Molecular Medicine (CMMC), University of Cologne, Cologne, Germany

    Thomas Krieg & Sabine A. Eming

Authors
  1. Anneke Brown
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Matthias Augustin
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Michael Jünger
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Markus Zutt
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Joachim Dissemond
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Eberhard Rabe
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Roland Kaufmann
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Margrit Simon
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Markus Stücker
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Sigrid Karrer
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Wolfgang Koenen
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Wolfgang Vanscheidt
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Karin Scharfetter-Kochanek
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Uwe Wollina
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Thomas Krieg
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Sabine A. Eming
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sabine A. Eming.

Additional information

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: http://clinicaltrials.gov/ct2/show/NCT00998673.

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Brown, A., Augustin, M., Jünger, M. et al. Randomized standard-of-care-controlled trial of a silica gel fibre matrix in the treatment of chronic venous leg ulcers. Eur J Dermatol 24, 210–216 (2014). https://doi.org/10.1684/ejd.2014.2344

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1684/ejd.2014.2344

Key words

Search

Navigation