Ditmars Frederick, Ducharme Sarah E, Lee Aliza M, Reems Jo-Anna, Fagg William Samuel, Markovic Jovan N
Department of Internal Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Int Wound J. 2025 Apr;22(4):e70171. doi: 10.1111/iwj.70171.
Non-healing venous leg ulcers represent a significant healthcare problem that accounts for about $32 billion of spending in the US alone. Consequently, novel treatment strategies represent a major unmet need. The current study (part one of Phase II study [NCT04647240]) assesses the safety, tolerability and efficacy of the use of cell-free human amniotic fluid in treating venous leg ulcers that did not heal following the correction of venous reflux. Patients received cell-free amniotic fluid injections in and around the wound either weekly or biweekly over 12 weeks. Primary outcomes included safety, tolerability and efficacy assessed by complete wound closure, wound area reduction and pain reduction. Eleven patients met enrollment eligibility, and nine completed the study. Five patients achieved complete wound closure by week 12. The average percent reduction in wound area was 83.7%, and pain scores were significantly lower by the study endpoint. No difference was observed in wound healing rates between weekly or biweekly treatment, but bi-weekly treatment was associated with nominally faster recovery. Patients tolerated the treatment, and no side effects were reported. These results indicate that cell-free amniotic fluid injection is a feasible, safe and effective treatment for non-healing venous leg ulcers.
难愈合的下肢静脉溃疡是一个重大的医疗保健问题，仅在美国每年的花费就约达320亿美元。因此，新的治疗策略是一个尚未满足的重大需求。当前这项研究（II期研究的第一部分 [NCT04647240]）评估了无细胞人羊水用于治疗在纠正静脉反流后仍未愈合的下肢静脉溃疡的安全性、耐受性和疗效。患者在12周内每周或每两周在伤口及其周围注射无细胞羊水。主要结局包括通过伤口完全闭合、伤口面积缩小和疼痛减轻来评估的安全性、耐受性和疗效。11名患者符合入组条件，9名完成了研究。5名患者在第12周时实现了伤口完全闭合。伤口面积平均缩小百分比为83.7%，到研究终点时疼痛评分显著降低。每周或每两周治疗的伤口愈合率没有差异，但每两周治疗名义上恢复得更快。患者耐受该治疗，且未报告有副作用。这些结果表明，注射无细胞羊水是治疗难愈合下肢静脉溃疡的一种可行、安全且有效的方法。
