Healing trajectories as an indicator of clinical outcomes in patients with venous leg ulcers

Background: Venous leg ulcers (VLUs) account for the majority of leg ulcers and are common among individuals with risk factors such as obesity or immobility. As a substudy of a large-scale, prospective, randomised double-blind, placebo-controlled trial, this substudy aimed to ascertain VLU healing rates and recurrence rates of patients excluded from the trial as they were deemed to be progressing along a normal healing trajectory. Methods: A wash-out entry-gate process was used to determine patients’ wound-healing trajectories. At the end of the 28-day wash-out process, patients whose VLUs were deemed to be following a normal healing trajectory continued to receive a standard treatment regimen and the healing and recurrence of ulcers in this patient group was assessed after 12 months. The primary endpoint was the incidence of complete wound healing at 1 year. Results: Forty-one patients from a total cohort of 141 were deemed to be following a normal healing trajectory at 28 days. One year later, 37% (n= 15) of the 41 patients’ ulcers had healed; however, 53% (n=8) of the ulcers had recurred in that period. Conclusion: There is a low VLU healing rate in patients with a normal healing trajectory, which suggests that healing trajectory is not a good indicator of healing and/or that current wound management for VLU is unsatisfactory.