Division of Surgery, Keck School of Medicine, University of Southern California, California, Los Angeles, USA.
Division of Research, Professional Education and Research Institute, Roanoke, Virginia, USA.
Int Wound J. 2023 Mar;20(3):853-860. doi: 10.1111/iwj.13932. Epub 2022 Aug 24.
The incidence and economic burden of diabetic foot ulcers continues to rise throughout the world. In this prospective study, a unique device designed to offload the wound, enhance circulation and monitor patient compliance was evaluated for safety and efficacy. The device provides offloading and intermittent plantar compression to improve the pedal flow of oxygenated blood and support wound healing while recording patient use. Ten patients with non-healing diabetic foot ulcers UTgrade 1A/Wagner grade 1 were treated weekly for up to 12 weeks. The primary endpoint was complete wound closure at 12 weeks, and secondary endpoints included healing time, percent area reduction and changes in pain using the visual analogue pain scale. Eight out of ten wounds healed within 12 weeks(80%), and the mean healing time was 41 days(95% CI:24.3-58.3). The percent area reduction was 75(SD:53.9). The baseline visual analogue pain scale was 4.5(2.9) as compared with 3.3(3.4) at end of study. No device-related or serious adverse events were reported. This unique intermediate plantar compression and offloading device may be considered as an alternative for safe and effective for treatment of non-healing diabetic foot ulcers. During treatment, wound healing was significantly accelerated, and pain was improved. Larger randomised controlled trials are underway to validate these early findings.
糖尿病足溃疡的发病率和经济负担在全球范围内持续上升。在这项前瞻性研究中，评估了一种独特的设备，该设备旨在减轻伤口负担、促进血液循环并监测患者依从性，以评估其安全性和有效性。该设备提供减压和间歇性足底压缩，以改善含氧血液的足部流动并支持伤口愈合，同时记录患者的使用情况。10 名非愈合性糖尿病足溃疡 UT 分级 1A/Wagner 分级 1 的患者每周接受治疗，最长可达 12 周。主要终点是 12 周时完全愈合，次要终点包括愈合时间、面积减少百分比和使用视觉模拟疼痛量表评估的疼痛变化。10 个伤口中有 8 个在 12 周内愈合（80%），平均愈合时间为 41 天（95%CI：24.3-58.3）。面积减少百分比为 75%（SD：53.9）。基线视觉模拟疼痛量表为 4.5（2.9），研究结束时为 3.3（3.4）。未报告与设备相关的或严重的不良事件。这种独特的中间足底压缩和减压设备可被视为治疗非愈合性糖尿病足溃疡的一种安全有效的替代方法。在治疗过程中，伤口愈合明显加快，疼痛得到改善。正在进行更大规模的随机对照试验来验证这些早期发现。
