Are Granulocyte Colony–Stimulating Factors Beneficial in Treating Diabetic Foot Infections?

A meta-analysis

  1. Mario Cruciani, MD1,
  2. Benjamin A. Lipsky, MD23,
  3. Carlo Mengoli, MD4 and
  4. Fausto de Lalla, MD5
  1. 1Center of Preventive Medicine, Verona, Italy
  2. 2General Internal Medicine Clinic, Veterans Affairs Puget Sound Health Care System, Seattle, Washington
  3. 3School of Medicine, University of Washington, Seattle, Washington
  4. 4Departments of Histology, Microbiology, and Medical Biotechnology, University of Padua, Padua, Italy
  5. 5Department of Infectious Diseases and Tropical Medicine, San Bortolo Hospital, Vicenza, Italy
  1. Address correspondence and reprint requests to Benjamin A. Lipsky, MD, FACP, FIDSA, Professor of Medicine, University of Washington, School of Medicine, Director, General Internal Medicine Clinic, VA Puget Sound Health Care System (S-111-GIMC), 1660 South Columbian Way, Seattle, WA 98108-1597. E-mail: benjamin.lipsky{at}med.va.gov

Abstract

OBJECTIVE—To assess the value of granulocyte colony–stimulating factor (G-CSF) as adjunctive therapy for diabetic foot infections.

RESEARCH DESIGN AND METHODS—We systematically searched the medical literature (including Medline, Embase, LookSmart, and the Cochrane Library) for prospective randomized studies that used G-CSF as an adjunct to standard treatment for diabetic foot infections. Using a conventional meta-analysis, we pooled the relative risks (RRs) for outcomes of interest, including resolution of infection, wound healing, duration of antibiotic therapy, and need for various surgical interventions, using a fixed-effects model.

RESULTS—Five randomized trials, with a total of 167 patients, met our inclusion criteria. The methodological quality of the studies was satisfactory. The investigators administered various G-CSF preparations parenterally for between 3 and 21 days. The meta-analysis revealed that adding G-CSF did not significantly affect the resolution of infection or the healing of the wounds but was associated with a significantly reduced likelihood of lower extremity surgical interventions (RR 0.38 [95% CI 0.20–0.69], number of patients who needed to be treated: 4.5), including amputation (0.41 [0.17–0.95], number of patients who needed to be treated: 8.6). There was no evidence of heterogeneity among the studies or of publication bias, suggesting that these conclusions are reasonably generalizable and robust.

CONCLUSIONS—Adjunctive G-CSF treatment does not appear to hasten the clinical resolution of diabetic foot infection or ulceration but is associated with a reduced rate of amputation and other surgical procedures. The small number of patients who needed to be treated to gain these benefits suggests that using G-CSF should be considered, especially in patients with limb-threatening infections.

Footnotes

    • Accepted October 31, 2004.
    • Received September 28, 2004.
| Table of Contents