Transplant Division, Department of Surgery, University of Texas Medical Branch, Galveston, TX 77551, US.
Department of Internal Medicine, Dell Medical School, Austin, TX 78712, US.
J Wound Care. 2024 Mar 1;33(Sup3):S44-S50. doi: 10.12968/jowc.2024.33.Sup3.S44.
Hard-to-heal (chronic) wounds negatively impact patients and are a source of significant strain on the healthcare system and economy. These wounds are often resistant to standard of care (SoC) wound healing approaches due to a diversity of underlying pathologies. Cellular, acellular, and matrix-like products, such as amniotic membranes (AM), are a potential solution to these challenges. A growing body of evidence suggests that AM may be useful for treatment-resistant wounds; however, limited information is available regarding the efficacy of dehydrated amniotic membrane (DHAM) on multi-aetiology, hard-to-heal wounds. Therefore, we analysed the efficacy of DHAM treatment in reducing the size of hard-to-heal diabetic and venous leg ulcers (VLUs) that had failed to improve after SoC-based treatments.
In this multicentre retrospective study, we analysed wound size during clinic visits for patients being treated for either diabetic or VLUs. During each visit, the treatment consisted of debridement followed by application of DHAM. Each wound was measured after debridement and prior to DHAM application, and wound volumes over time or number of DHAM applications were compared.
A total of 18 wounds in 11 patients were analysed as part of this study. Wounds showed a significant reduction in volume after a single DHAM application, and a 50% reduction in wound size was observed after approximately two DHAM applications. These findings are consistent with reports investigating DHAM treatment of diabetic ulcers that were not necessarily resistant to treatment.
To our knowledge, this study is the first to directly compare the efficacy of standalone DHAM application to hard-to-heal diabetic and venous leg ulcers, and our findings indicate that DHAM is an effective intervention for resolving these types of wounds. This suggests that implementing this approach could lead to fewer clinic visits, cost savings and improved patient quality of life.
This research was supported in part by Merakris Therapeutics, US, and facilitated access to deidentified patient datasets, which may represent a perceived conflict of interest; however, the primary data analysis was performed by FSB who is unaffiliated with Merakris Therapeutics. TCB is a founder, employee of and shareholder in Merakris Therapeutics; WSF is a co-founder of, consultant for, and shareholder in Merakris Therapeutics, and was also supported by the National Institutes of Health National Center for Advancing Translational Sciences Clinical and Translational Science Awards Grant KL2 Scholars Program (KL2TR001441). The research was also supported through endowments to WSF from the University of Texas Medical Branch Mimmie and Hallie Smith Endowed Chair of Transplant Research and the John L Hern University Chair in Transplant Surgery.
难以愈合（慢性）伤口对患者有负面影响，是医疗系统和经济的重大负担。这些伤口由于多种潜在的病理原因，往往对标准的伤口愈合方法（SoC）有抵抗力。细胞外基质、去细胞和类似基质的产品，如羊膜（AM），是解决这些挑战的潜在方法。越来越多的证据表明，AM 可能对治疗抵抗性伤口有用；然而，关于脱水羊膜（DHAM）对多病因、难以愈合的伤口的疗效的信息有限。因此，我们分析了 DHAM 治疗在减少因 SoC 治疗后仍未改善的糖尿病和静脉性腿部溃疡（VLU）的大小方面的疗效。
在这项多中心回顾性研究中，我们分析了因糖尿病或 VLUs 接受治疗的患者在就诊时的伤口大小。每次就诊时，治疗包括清创，然后应用 DHAM。每次清创后和应用 DHAM 前都要测量伤口，并比较伤口体积随时间的变化或 DHAM 应用的次数。
作为本研究的一部分，共分析了 11 名患者的 18 个伤口。单次 DHAM 应用后，伤口体积明显缩小，应用两次 DHAM 后，伤口面积缩小 50%。这些发现与非治疗抵抗性糖尿病溃疡的 DHAM 治疗报告一致。
据我们所知，这项研究首次直接比较了单独应用 DHAM 治疗难以愈合的糖尿病和静脉性腿部溃疡的疗效，我们的研究结果表明，DHAM 是解决这些类型伤口的有效干预措施。这表明，实施这种方法可能会减少就诊次数、节省成本和提高患者的生活质量。
这项研究得到了美国 Merakris Therapeutics 的部分支持，并为我们提供了获取去标识化患者数据集的机会，这可能代表了一种潜在的利益冲突；然而，主要的数据分析是由 FSB 进行的，FSB 与 Merakris Therapeutics 无关。TCB 是 Merakris Therapeutics 的创始人、员工和股东；WSF 是 Merakris Therapeutics 的联合创始人、顾问和股东，同时还得到了美国国立卫生研究院国家推进转化科学中心临床和转化科学奖 KL2 学者计划（KL2TR001441）的支持。这项研究还得到了德克萨斯大学医学分校 Mimmie 和 Hallie Smith 移植研究 endowed 主席和 John L Hern 移植外科 endowed 主席的捐赠。
