Lavery Lawrence, Fulmer James, Shebetka Karry Ann, Regulski Matthew, Vayser Dean, Fried David, Kashefsky Howard, Owings Tammy M, Nadarajah Janaki, Hesp Zoe
Howard Hughes Medical Institute - University of Texas Southwestern Medical Center at Dallas, Dallas, TX
River City Clinical Research, Jacksonville, FL
Wounds. 2018 Sep;30(9):283-289. Epub 2018 Jun 29.
The results of the single-arm, open-label extension phase of the Grafix (cryopreserved placental membrane; CPM; Osiris Therapeutics, Inc, Columbia, MD) multicenter, blinded, randomized, controlled clinical trial for chronic diabetic foot ulcers (DFUs) is reported.
Twenty-six patients in the standard wound care (SWC) arm whose DFUs did not close in the blinded phase chose to receive weekly applications of the CPM in an open-label extension phase.
In the extension phase, 17 (65.4%) patients closed their wounds in a median of 34 days and 3 visits. There were fewer total adverse events (AEs) (24 CPM vs. 52 SWC) and index wound-related infections (5 CPM vs. 12 SWC) during the CPM application compared with the number of AEs for the same patients during the SWC treatment in the blinded phase of the trial.
These results corroborate the benefits of this CPM combined with SWC over SWC alone for chronic DFUs previously reported for the blinded randomized phase of the trial, which directly relate to lower health care costs.
报告Grafix（冷冻保存胎盘膜；CPM；奥西里斯治疗公司，马里兰州哥伦比亚）多中心、双盲、随机、对照临床试验针对慢性糖尿病足溃疡（DFU）的单臂、开放标签扩展阶段的结果。
标准伤口护理（SWC）组中有26例患者，其DFU在双盲阶段未愈合，他们选择在开放标签扩展阶段接受每周一次的CPM治疗。
在扩展阶段，17例（65.4%）患者的伤口在中位时间34天及3次就诊后愈合。与试验双盲阶段这些患者接受SWC治疗期间的不良事件数量相比，CPM应用期间的总不良事件（AE）较少（CPM组24例 vs. SWC组52例），且与指数伤口相关的感染较少（CPM组5例 vs. SWC组12例）。
这些结果证实了与单独使用SWC相比，这种CPM联合SWC对慢性DFU的益处，这与之前试验双盲随机阶段报告的结果一致，且直接关系到更低的医疗成本。
