Barry University Clinical Research, North Miami Beach, FL, US.
Olive View UCLA Education & Research Institute, Sylmar, CA, US.
J Wound Care. 2024 Sep 2;33(9):688-700. doi: 10.12968/jowc.2024.0195. Epub 2024 Aug 30.
Diabetic foot ulcers (DFUs) present a significant global health challenge, resulting in high morbidity and economic costs. Current available treatments often fail to achieve satisfactory healing rates, highlighting the need for novel therapies. This study evaluated the safety and efficacy of a novel autologous whole blood clot (AWBC)-a blood-based, biodegradable provisional matrix-in conjunction with standard of care (SoC) when compared to SoC alone in the treatment of hard-to-heal DFUs.
A multicentre, prospective, blinded assessor, randomised controlled trial was conducted at 16 sites across the US, South Africa and Turkey. A cohort of patients with hard-to-heal DFUs was enrolled and randomised to either the AWBC group or the control group. The primary endpoint was complete wound closure at 12 weeks, while secondary endpoints included time to heal and percentage area reduction (PAR) at four and eight weeks. Data were analysed using both intention-to-treat (ITT) and per-protocol (PP) populations.
The cohort included 119 patients. AWBC treatment resulted in a significantly higher healing rate compared to the control in both ITT (41% versus 15%, respectively; p=0.002) and PP populations (51% versus 18%, respectively; p=0.0075). AWBC treatment also resulted in a shorter mean time to heal and higher durability of wound closure. Safety analysis showed a similar incidence of adverse events (AEs) between groups, with no device-related AEs.
The AWBC system, by modulating the wound microenvironment and providing a functional extracellular matrix, offered a promising new approach to treating hard-to-heal DFUs, demonstrating superior healing outcomes compared to SoC alone in this study.
糖尿病足溃疡（DFU）是一个重大的全球健康挑战，导致高发病率和经济成本。目前可用的治疗方法往往无法达到令人满意的愈合率，这突显了需要新的治疗方法。本研究评估了新型自体全血凝块（AWBC）-一种基于血液的、可生物降解的临时基质-与标准治疗（SoC）联合使用与单独使用 SoC 相比，在治疗难以愈合的 DFU 方面的安全性和疗效。
在美国、南非和土耳其的 16 个地点进行了一项多中心、前瞻性、盲法评估、随机对照试验。招募了一组患有难以愈合的 DFU 的患者，并将其随机分配到 AWBC 组或对照组。主要终点是 12 周时完全愈合，次要终点包括愈合时间和第 4 周和第 8 周时的面积减少百分比（PAR）。使用意向治疗（ITT）和方案人群（PP）对数据进行了分析。
该队列包括 119 名患者。在 ITT（分别为 41%和 15%，p=0.002）和 PP 人群（分别为 51%和 18%，p=0.0075）中，AWBC 治疗的愈合率明显高于对照组。AWBC 治疗还导致愈合时间更短，伤口闭合的耐久性更高。安全性分析显示，两组不良事件（AE）的发生率相似，无与器械相关的 AE。
AWBC 系统通过调节伤口微环境并提供功能性细胞外基质，为治疗难以愈合的 DFU 提供了一种有前途的新方法，与本研究中单独使用 SoC 相比，显示出更好的愈合结果。
