A randomised comparative trial on the use of a hydrogel with tepescohuite extract (Mimosa tenuiflora cortex extract-2G) in the treatment of venous leg ulcers

Tepescohuite is an extract obtained from the bark of the Mimosa tenuiflora tree and is used as an empirical treatment in wounds for its healing and antiseptic properties. Venous leg ulcers (VLUs) are a common health care problem in most countries with a high rate of morbidity. The standard of care is moist interactive healing and compression; however, the ideal topical treatment is yet to be established. This study is designed to evaluate the effectiveness and safety of M. tenuiflora cortex extract (MTC-2G) in the treatment of VLUs in an Interdisciplinary Wound and Ostomy Care Center (IWOCC). A randomised, placebo-controlled, double blind clinical trial was conducted to compare the use of a hydrogel containing MTC-2G with the hydrogel alone in VLUs. The study included all patients with venous ulcers referred to the IWOCC. Laboratory tests and tissue biopsies were performed at the beginning and at the end of the study. The patients were instructed to daily cleansing followed by topical application of the hydrogel and compression. Forty-one patients were included, 22 patients received the MTC-2G and 19 patients received the hydrogel only. Of the 41 patients, 32 completed the study, 18 in the experimental arm and 14 in the control group, 19 were women and 13 men. The mean age of the subjects was 60 years. The mean time from presentation was 38 months. The mean surface reduction was 6.29 cm2 [confidence interval (IC) 95%: 3.289.29] (P = 0.0001) in the MTC-2G group and 5.85 cm2 (95% CI: 3.588.12) (P = 0.001) in the hydrogel group. There was no significant difference between the groups (P = 0.815). No changes in the laboratory parameters were noted. In the histology, there were not any differences between groups either. A hydrogel containing MTC-2G was not superior to a hydrogel alone in the treatment of VLUs.