OBJECTIVE: To determine the safety, tolerability, and efficacy of TGF-β3 in the treatment of chronic, nonhealing pressure ulcers.
DESIGN: A subset analysis of data from a randomized, blind, parallel, placebo-controlled trial involving 270 patients.
SETTING: University of Michigan Wound Care Center.
PATIENTS: A total of 14 patients (6 women and 8 men aged ≥18 years) with pressure ulcers were randomly assigned to 1 of 3 groups to receive once daily topical application of recombinant TGF-β3 or placebo gel for a period of no more than 16 weeks. Group 1 (n=4) received 1.0 μg/cm2 of TGF-β3, Group 2 (n=5) received 2.5 μg/cm2 of TGF-β3, and Group 3 (n=5) received placebo gel. All subjects received standardized wound care as well. Weekly evaluations were performed for efficacy, determined by relative wound surface areas and volumes, and were compared with initial baseline values and safety parameters.
MAIN OUTCOME MEASURE: Reduction in pressure ulcer area and volume.
MAIN RESULTS: Group 2 had a significantly increased rate of wound healing at the fourth visit (P <.05). No significant difference was observed in the healing rate among the groups at the termination of the study. Treatment with TGF-β3 was well tolerated and there were no significant adverse reactions.
CONCLUSION: The findings of this study indicate that the topical application of TGF-β3 is safe and useful in the treatment of pressure ulcers and is most effective at the earliest stages of therapy.
James Hirshberg, BS, is a medical student at the University of Michigan, Ann Arbor, MI. James Coleman, MD, is a resident and Beverly Marchant, RN, is a wound care coordinator in the Section of Plastic and Reconstructive Surgery, Department of Surgery, University of Michigan Medical Center, Ann Arbor, MI. Riley S. Rees, MD, FACS, is Professor of Surgery, Section of Plastic and Reconstructive Surgery, Department of Surgery, University of Michigan Medical Center, and Chief of Plastic Surgery, Veterans Affairs Medical Center, Ann Arbor, MI.
This paper is based on work supported by the Office of Research and Development, Medical Research Service, Department of Veterans Affairs.
Submitted February 3, 2000; accepted in revised form May 17, 2000.