OBJECTIVE: To construct an easy-to-use severity scale based on data from a multicenter venous leg ulcer trial to predict which wounds will progress toward closure and which will remain unhealed.
DESIGN: Factors that have an impact on wound healing (eg, ulcer duration, depth, area, location, and fibrin) were identified in the literature. A severity scale was constructed based on these factors.
SETTING: Multicenter clinical trial.
PATIENTS: 240 patients with venous leg ulcers of longer than 1 month’s duration.
MAIN RESULTS: Wound duration and area were identified as having the greatest impact on ulcer healing. Using multivariate regression analyses, a wound score of 8 or less was considered mild to moderate. A severe wound, having a score of 9 or greater, was found to be unlikely to heal with compression therapy alone.
CONCLUSION: This severity scale can serve as an adjunctive tool in the prompt identification of ulcers with a poor healing prognosis and enable early intervention with alternate therapies. To optimize the severity scale, future trials should incorporate a method to review the interaction of known factors that impair wound healing.
Morris D. Kerstein, MD, FACS, is Chief of Staff at the Veterans Administration Hospital, Wilmington, DE. Harold Brem, MD, is Assistant Professor, Department of Surgery, and Director, Wound Healing Center, The Mount Sinai Medical Center, New York, NY.
Katherine B. Giovino is Assistant Director of Clinical Research, Medical and Regulatory Affairs, Organogenesis, Inc, Canton, MA.
Michael Sabolinski, MD, is Senior Vice-President, Medical and Regulatory Affairs, Organogenesis, Inc, Canton, MA.
The authors thank Gae O. Decker-Garrad for editorial assistance.
Submitted June 26, 2000; accepted in revised form February 7, 2001.