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Our multicenter study was established by following a rigid protocol suggested to us by the US Food and Drug Administration (FDA). The studies were performed in four different rehabilitation programs where many patients have continuing problems with decubitus ulcers. Only the worst cases were selected for the trial. The ulcers treated had not responded to traditional methods for a minimum period of 5 months. The mean age of the population in the experimental group was 75.6 years and in the control group 74.9 years. In these patients, several ulcers increased in diameter during the normal control treatment regimen (ie, wound cleansing, moist dressings, and whirlpool baths). Ulcers on the lower extremities (eg, toes and ankles) were mostly selected because they are known to be poor responders to traditional methods. Patients in the placebo group were treated after the 8-week protocol and all 31 control ulcers responded. The photographs presented in