Topical Treatment of Pressure Ulcers with Nerve Growth Factor

A Randomized Clinical Trial

  1. Francesco Landi, MD, PhD;
  2. Luigi Aloe, MD;
  3. Andrea Russo, MD;
  4. Matteo Cesari, MD;
  5. Graziano Onder, MD;
  6. Stefano Bonini, MD;
  7. Pier Ugo Carbonin, MD; and
  8. Roberto Bernabei, MD
  1. From Catholic University of the Sacred Heart, Rome, Italy; Teaching Nursing Home, Santa Maria della Pace, Catholic University of the Sacred Heart, Fontecchio, Italy; Institute of Neurobiology and Molecular Medicine, National Research Council, Rome, Italy; J. Paul Sticht Center on Aging and Rehabilitation, Wake Forest University–Baptist Medical Center, Winston-Salem, North Carolina; and Bietti Foundation, Campus Biomedico University, Rome, Italy.

    Abstract

    Background: The prevalence of pressure ulcers of the foot is a major health care problem in frail elderly patients. A pressure sore dramatically increases the cost of medical and nursing care, and effective treatment has always been an essential nursing concern. Management options for pressure ulcers include local wound care; surgical repair; and, more recently, topical application of growth factors.

    Objective: To examine the effects of topical treatment with nerve growth factor in patients with severe, noninfected pressure ulcers of the foot.

    Design: Randomized, double-blind, placebo-controlled trial.

    Setting: Teaching nursing home of Catholic University of the Sacred Heart, Italy.

    Patients: 36 persons with pressure ulcers of the foot.

    Intervention: 18 patients received nerve growth factor treatment, and 18 patients received only conventional topical treatment.

    Measurements: The course of the ulcers during follow-up was evaluated by tracing the perimeter of the wound onto sterile, transparent block paper and determining the stage.

    Results: At baseline, the treatment and control groups did not differ across demographic variables, clinical characteristics, and functional measures. The mean area (±SD) of the ulcers was 1012 ± 633 mm2 in the treatment group and 1012 ± 655 mm2 in the control group (P > 0.2). The average reduction in pressure ulcer area at 6 weeks was statistically significantly greater in the treatment group than in the control group (738 ± 393 mm2 vs. 485 ± 384 mm2; P = 0.034).

    Conclusion: Topical application of nerve growth factor may be an effective therapy for patients with severe pressure ulcers.

    Article and Author Information

    • Acknowledgments: The authors thank Professor Rita Levi-Montalcini for her encouragement in the realization of the study. They also thank S. Torre, MD; A. De Santis, HN; and all of the nursing home staff of Opera Santa Maria della Pace, Teaching Nursing Home of Fontecchio, for their contribution to the study protocol.

    • Grant Support: By a grant from the Progetto Finalizzato Invecchiamento of the Italian National Research Council. Support was also provided by interRAI, an international group of clinicians and researchers who collaborate to promote research on resident assessment instruments and quality outcomes for elderly persons. Dr. Aloe was supported by a grant from the Italian National Institute of Health (ICG 120/4RA00-90) and by a grant from the Italian National Research Council, FISR/Neurobiotechnology (192/03).

    • Potential Financial Conflicts of Interest: None disclosed.

    • Requests for Single Reprints: Francesco Landi, MD, PhD, Department of Geriatrics, Catholic University of the Sacred Heart, Largo Agostino Gemelli, 8, 00168 Rome, Italy; e-mail, francesco_landi{at}rm.unicatt.it.

    • Current Author Addresses: Drs. Landi, Carbonin, and Bernabei: Department of Geriatrics, Catholic University of the Sacred Heart, Largo Agostino Gemelli, 8, 00168 Rome, Italy.

    • Dr. Aloe: Institute of Neurobiology and Molecular Medicine, National Research Council, Viale Marx, 15/43, 00137 Rome, Italy.

    • Dr. Russo: Teaching Nursing Home, Santa Maria della Pace, Catholic University of the Sacred Heart, 67020 Fontecchio (AQ), Italy.

    • Drs. Cesari and Onder: J. Paul Sticht Center on Aging and Rehabilitation, Wake Forest University–Baptist Medical Center, Medical Center Boulevard, Winston-Salem, NC 27157.

    • Dr. Bonini: Bietti Foundation, Campus Biomedico University, 00137 Rome, Italy.

    • Author Contributions: Conception and design: F. Landi, S. Bonini, P.U. Carbonin, R. Bernabei.

    • Analysis and interpretation of the data: F. Landi, M. Cesari, G. Onder.

    • Drafting of the article: F. Landi.

    • Critical revision of the article for important intellectual content: L. Aloe, A. Russo, S. Bonini.

    • Final approval of the article: P.U. Carbonin, R. Bernabei.

    • Provision of study materials or patients: L. Aloe.

    • Statistical expertise: M. Cesari, G. Onder.

    • Collection and assembly of data: A. Russo.

    Summary for Patients

    • Summaries for Patients:Nerve Growth Factor Improves Healing of Pressure Ulcers of the Foot Ann Intern Med October 21, 2003 139:I-10
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    1. Ann Intern Med October 21, 2003 vol. 139 no. 8 635-641
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