Skip to main content
SpringerLink
Log in

Treatment of chronic ulcers in the lower extremities with topical becaplermin gel .01%: A multicenter open-label study

  • Published:
Advances in Therapy Aims and scope Submit manuscript

Abstract

This prospective, multicenter, open-label study assessed the efficacy and tolerability of recombinant human platelet-derived growth factor BB (becaplermin) in the treatment of chronic ulcers of the lower extremities in 73 patients with and without type 2 diabetes mellitus. Becaplermin gel .01% was applied once daily for 12 weeks. Efficacy was assessed in terms of progression to healing (100% epithelialization); the secondary efficacy endpoint was time to complete healing. Safety was assessed in terms of incidence of adverse events. Ninety-five percent of all ulcers were completely healed at week 9; only 5% remained incompletely healed at week 12 and were considered treatment failures. Healing time did not differ between diabetic and nondiabetic patients. The major adverse events were pain, burning sensation, and pruritus at the ulcer site, with an overall incidence of 10%. No patients dropped out because of adverse events. Becaplermin gel .01 % was safe and well tolerated. Further studies are necessary to assess the durability of healing with this treatment.

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

References

  1. Callan MJ, Harper DR, Dale JJ, Ruckley CV. Chronic leg ulcers: socioeconomic aspects.Scott Med J. 1988;33:358–360.

    Google Scholar 

  2. Evans CJ, Fowkes FG, Hajivassiliou CA, et al. Epidemiology of varicose veins: a review.Int Angiol. 1994;13:263–270.

    PubMed  CAS  Google Scholar 

  3. Ibrahim S, MacPherson DR, Goldhaber SZ. Chronic venous insufficiency: mechanism and management.Am Heart J. 1996;132:856–860.

    Article  PubMed  CAS  Google Scholar 

  4. Cheatle TR, Scurr JH, Coleridge Smith PD. Drug treatment of chronic venous insufficiency and venous ulceration: a review.J R Soc Med. 1991;84:354–358.

    PubMed  CAS  Google Scholar 

  5. Jain KK. Pathophysiology and pharmacotherapy of chronic venous insufficiency: a critical review.J Clin Res. 1998;1:269–288.

    Google Scholar 

  6. Bennett NF, Schultz GS. Growth factors and wound healing, II: role in normal and chronic wound healing.Am J Surg. 1993;166:74–81.

    Article  PubMed  CAS  Google Scholar 

  7. Stadelman WK, Digenis AG, Tobin GR. Impediments to wound healing.Am J Surg. 1998; 176(suppl 2A):48S-54S.

    Google Scholar 

  8. Robson MC, Mustoe TA, Hundt TK. The future of recombinant growth factors in wound healing.Am J Surg. 1998;176(suppl 2A):80S-82S.

    Article  PubMed  CAS  Google Scholar 

  9. Ksander GA, Chu GH, McMullin H, et al. Transforming growth factors β1 and β2 enhance connective tissue formation in animal models of dermal wound healing by secondary intent.Ann NYAcad Sci. 1990;593:135–147.

    Article  CAS  Google Scholar 

  10. Smiell JM, Becaplermin Studies Group. Clinical safety of becaplermin (rhPDGF-BB) gel.Am J Surg. 1998;176(suppl 2A):68S-73S.

    Article  PubMed  CAS  Google Scholar 

  11. The National Pressure Ulcer Advisory Panel. Pressure ulcers prevalence, cost and risk assessment: Consensus Development Conference statement.Decubitus. 1989;2:24–28.

    Google Scholar 

  12. Dermal wounds: pressure sores. Philosophy of the IAET.J Enterostomal Ther. 1988;15:4–17.

    Google Scholar 

  13. Ruckley CV. Socioeconomic impact of chronic venous insufficiency and leg ulcers.Angiology. 1997;48:67–69.

    Article  PubMed  CAS  Google Scholar 

  14. Robson MC. Exogenous growth factor application: effect on human wound healing.Prog Dermatol. 1996;30:1–7.

    Google Scholar 

  15. Puolakkainen PA, Twardzik DR, Ranchalis JE, et al. The enhancement in wound healing by transforming growth factor β1 (TGFβ1) depends on the topical delivery system.J Surg Res. 1995;58:321–329.

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Garcia Vigil No. 304, 68000, Oaxaca Oaxaca, Mexico

    E. Guzman-Gardearzabal M.D. & G. Leyva-Bohorquez

  2. Hospital Central Norte, Pemex-Azcapotzalco, Mexico City

    S. Salas-Colín

  3. Hospital Español, Mexico City

    J. L. Paz-Janeiro

  4. Hospital Regional, “Dr. Santiago Ramón y Cajal” ISSSTE, Durango

    R. Alvarado-Ruiz

  5. Hospital Regional, “Dr. Darío Fernández” ISSSTE, Mexico City, Mexico

    R. García-Salazar

Authors
  1. E. Guzman-Gardearzabal M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. G. Leyva-Bohorquez
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. S. Salas-Colín
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. J. L. Paz-Janeiro
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. R. Alvarado-Ruiz
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. R. García-Salazar
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Guzman-Gardearzabal, E., Leyva-Bohorquez, G., Salas-Colín, S. et al. Treatment of chronic ulcers in the lower extremities with topical becaplermin gel .01%: A multicenter open-label study. Adv Therapy 17, 184–189 (2000). https://doi.org/10.1007/BF02850294

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF02850294

Keywords

Search

Navigation