Is Complete Wound Healing a Valid Endpoint for Clinical Trials of Venous Stasis Ulcer Treatment

Complete wound healing is often used as an endpoint in clinical trials comparing different treatments of venous stasis ulcers. The authors have found, however, that determining exactly when a wound is completely healed is often difficult and quite subjective. Because of this concern, they undertook the following survey.Photographs of 46 venous stasis ulcers were classified by the authors as obviously healed (H, n=5), obviously not healed (NH, n=7), and ambiguous (Amb, n=34). Blinded reviewers were instructed to judge the wounds as if they were conducting a clinical trial, and were asked: (1) Is the wound healed? (yes/no/can't tell), and (2) If forced to decide yes or no for question 1, which would you choose? (yes/no).Forty-eight reviewers took part in the study: 29 physicians or nurse clinicians with a specialty in wound care (MD/RN) and 19 medical students (MS). When given the three options, they classified 17% of the wounds as "can't tell" (H 27%, NH 5%, Amb 17%). The percentage of reviewers disagreein...