Analysis of data
ulcer, pain
ULCER
The statistical analysis to assess the efficacy and safety end points was carried out using SAS® Version 9.4 (SAS Institute Inc., USA). Data are presented as mean ± SD. Normality of continuous data was tested using Shapiro–Wilk test. Change in rest pain, ulcer size, ABPI, ASP, improvement in TWD and QoL from baseline to each visit were evaluated using Wilcoxon sign rank test or paired t test based on normality of the data. The efficacy parameters were also analyzed by using a generalized estimating equation (GEE) model with longitudinal analysis and chi-square test as appropriate. A 