Lubarsky Ryan, Gusenoff Beth, Gusenoff Jeffrey A
University of Pittsburgh Medical Center, Pittsburgh, Pa.
Department of Plastic Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.
Plast Reconstr Surg Glob Open. 2021 Nov 24;9(11):e3950. doi: 10.1097/GOX.0000000000003950. eCollection 2021 Nov.
Pressure offloading is often considered a crucial factor affecting healing after a foot injury. We have devised a novel foot offloading device (PopSole) which allows for immediate customization of the area where there is foot pain and allows for adjustable arch support and metatarsal pad height while maintaining patient stability. We hypothesize that pain and function outcomes will improve significantly after use of the device over a 1-month period. Ten participants with foot pain for longer than 6 months completed five validated outcome questionnaires during three visits (initial screening, at 2 weeks, and at 4 weeks). Devices were deflated in areas of pain specific for each patient. Validated patient reported outcomes measures showed significant improvement in pain and function from baseline to week two (r = 0.644, 0.05), (r = 0.43, 0.05), and (r = 0.552, 0.05), respectively, and the Foot & Ankle Ability Measure (FAAM) showed improved ability in activities of daily living (r = 0.58, 0.05) and sports (r = 0.69, 0.05). All 10 patients reported pain relief during at least one visit and/or an ability to return to standing-based activities that they previously were unable to do. PopSole rapidly improved pain and function, with sustained relief through 4 weeks. Current studies are in progress to assess long-term durability of the device and potential modifications to be made before future randomized studies to assess pressure and gait assessment, shear forces, and diabetic foot ulcer mitigation.
减轻压力通常被认为是影响足部受伤后愈合的关键因素。我们设计了一种新型的足部减压装置（PopSole），它能够即时定制足部疼痛区域，在保持患者稳定性的同时，还能调节足弓支撑和跖骨垫高度。我们假设，使用该装置1个月后，疼痛和功能结果将显著改善。10名足部疼痛超过6个月的参与者在三次就诊（初始筛查、2周时和4周时）期间完成了五份经过验证的结果问卷。装置在每位患者特定的疼痛区域进行放气。经过验证的患者报告结果测量显示，从基线到第2周，疼痛和功能有显著改善（r = 0.644，P < 0.05）、（r = 0.43，P < 0.05）和（r = 0.552，P < 0.05），足部与踝关节功能测量（FAAM）显示日常生活活动能力（r = 0.58，P < 0.05）和运动能力（r = 0.69，P < 0.05）有所提高。所有10名患者均报告在至少一次就诊期间疼痛缓解，和/或能够恢复到他们之前无法进行的站立活动。PopSole迅速改善了疼痛和功能，并在4周内持续缓解。目前正在进行研究，以评估该装置的长期耐用性，以及在未来进行随机研究以评估压力和步态评估、剪切力和糖尿病足溃疡缓解之前可能需要进行的潜在改进。
