Venous lower limb ulcers are very common and affect ~1% of the general population. The human acellular amniotic membrane (HAAM), which is isolated from the amniotic membrane (AM) via excluding the majority of cellular components, has lower antigenicity than the AM. The aim of the present study was to evaluate the effectiveness and safety of the HAAM, adopted to treat venous ulcers (VUs) of the lower extremities. The HAMM was isolated from the AM by the Stem Cells and Tissue Engineering laboratory at the West China Hospital of Sichuan University (Chengdu, China). HAMMs were grafted onto VUs in 4 patients, with follow-up evaluations performed on the 3rd day and at the end of the 1st, 2nd and 3rd week, and 2nd, 3rd and 6th month after the HAAMs were applied. The size and depth of the VU (determined based on whether the depth of VU reaches the tibial plane), the proportion of granulation tissue (whether >50%) and the degree of secretion (measured by asessing the degree of satuation in the outer gauze) and infection (assessed qualitatively via the appearance of purulence or peripheral swelling) were assessed. Pain score was monitored at the same intervals using a visual analog scale. Complete epithelialization (healed tissue) occurred in 2 cases: The first at the end of the 3rd week and the second, at the 2nd month following HAAM induction. In one of the remaining cases, ulcer size was reduced by >60%; however the ulcer size of the remaining case only reduced by <20%. Overall, the size of ulcer in cases 1, 2, 3 and 4 decreased to 1.2×1.1 and 1.4×0.4 cm, 1.3×1.8 and 2.3×1.4, respectively, with evident decreases in ulcer depth. The proportion of granulation tissue in each case was >50%. Furthermore, purulence and secretion completely disappeared in all 4 cases. Additionally, the medical cost of HAAM treatment is substantially lower than that of AM treatment, skin autografts and biomaterial transplantation, thus alleviating the patients' financial burden. These findings suggest that HAMM was highly effective in treating VUs in patients.
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