Efficacy evaluation
ulcerations, ulcer, Ulcer, pain
SECONDARY, ULCERATIONS, ULCER, ULCER
The primary efficacy assessment was the relief of rest pain and the healing of ulcerations in the target limb. Complete ulcer healing was defined as complete epithelization of ulcer (100% reduction in ulcer size from the baseline assessment) and partial ulcer healing as at least 30% decrease in ulcer size to the baseline assessment. Ulcer size in cmThe secondary efficacy assessment included improvement in ankle–brachial blood pressure (ABPI) and ankle systolic pressure (ASP) measured by Doppler, improvement in total walking distance (TWD) as measured by treadmill, improvement in quality of life (QoL) as measured by the King’s College VascuQOL questionnaire and major amputation-free survival.