San Antonio New Step, San Antonio, TX 78229, US.
Palm Beach Foot & Ankle, Palm Beach Gardens, FL 33410, US.
J Wound Care. 2024 Mar 1;33(Sup3):S16-S23. doi: 10.12968/jowc.2024.33.Sup3.S16.
The aim of this retrospective case series was to report on the outcomes of diabetic foot ulcers (DFUs) managed with hypothermically stored amniotic membrane (HSAM).
Deidentified case data of patients who received HSAM were obtained from wound care sites across the US. Data were collected, beginning at the first patient visit to the wound care site (first presentation), at the visit in which the first HSAM application occurred (baseline), and at each subsequent visit over 12 weeks of treatment (follow-up). All patients received standard of care (SoC) between first presentation and baseline.
Of the 50 patients in the study, 68% were male. Mean age of the entire cohort was 66.7 years. Of the DFUs, 88% were present for <6 months at first presentation. Mean wound area was 3.5cm, and mean percentage area reduction was -68.3% from first presentation to baseline. The mean number of HSAM applications was 5.5, and mean number of days between applications was 7.5. A >60% area reduction was attained in 96.0% of DFUs, and 78% attained complete wound closure (CWC) by week 12. The median time to CWC was 55 days.
The results of this retrospective case series suggest positive outcomes for DFUs managed with HSAM. A reduction in time to CWC may lead to lesser financial burden and improved quality of life for DFU patients.
The authors have no conflicts of interest.
本回顾性病例系列研究的目的是报告使用低温保存羊膜(HSAM)治疗糖尿病足溃疡(DFU)的结果。
从美国各地的伤口护理机构获取接受 HSAM 治疗的患者的匿名病例数据。数据收集从患者首次就诊至伤口护理机构(首次就诊)开始,在首次 HSAM 应用发生时(基线)以及在治疗的 12 周内每次后续就诊时进行(随访)。所有患者在首次就诊和基线之间均接受标准护理(SoC)。
在这项研究的 50 名患者中,68%为男性。整个队列的平均年龄为 66.7 岁。在所有 DFU 中,88%在首次就诊时存在<6 个月。平均伤口面积为 3.5cm,从首次就诊到基线的平均面积减少百分比为-68.3%。HSAM 的平均应用次数为 5.5 次,应用之间的平均天数为 7.5 天。96.0%的 DFU 达到了>60%的面积减少,78%的 DFU 在第 12 周达到了完全伤口闭合(CWC)。达到 CWC 的中位数时间为 55 天。
这项回顾性病例系列研究的结果表明,使用 HSAM 治疗 DFU 可取得良好的效果。缩短达到 CWC 的时间可能会减轻 DFU 患者的经济负担并提高生活质量。
作者无利益冲突。