Prospective Cohort Validation Study of a Novel Foot Offloading Device

Summary:. 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 h...

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Autores principales:	Ryan Lubarsky, BA, Beth Gusenoff, DPM, Jeffrey A. Gusenoff, MD
Formato:	article
Lenguaje:	EN
Publicado:	Wolters Kluwer 2021
Materias:	Surgery RD1-811
Acceso en línea:	https://doaj.org/article/79eb12d258e94cd9aa0f3f6f44cfcdb1
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spelling	oai:doaj.org-article:79eb12d258e94cd9aa0f3f6f44cfcdb12021-11-25T07:58:04ZProspective Cohort Validation Study of a Novel Foot Offloading Device2169-757410.1097/GOX.0000000000003950https://doaj.org/article/79eb12d258e94cd9aa0f3f6f44cfcdb12021-11-01T00:00:00Zhttp://journals.lww.com/prsgo/fulltext/10.1097/GOX.0000000000003950https://doaj.org/toc/2169-7574Summary:. 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, P < 0.05), (r = 0.43, P < 0.05), and (r = 0.552, P < 0.05), respectively, and the Foot & Ankle Ability Measure (FAAM) showed improved ability in activities of daily living (r = 0.58, P < 0.05) and sports (r = 0.69, P < 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.Ryan Lubarsky, BABeth Gusenoff, DPMJeffrey A. Gusenoff, MDWolters KluwerarticleSurgeryRD1-811ENPlastic and Reconstructive Surgery, Global Open, Vol 9, Iss 11, p e3950 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Surgery RD1-811
spellingShingle	Surgery RD1-811 Ryan Lubarsky, BA Beth Gusenoff, DPM Jeffrey A. Gusenoff, MD Prospective Cohort Validation Study of a Novel Foot Offloading Device
description	Summary:. 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, P < 0.05), (r = 0.43, P < 0.05), and (r = 0.552, P < 0.05), respectively, and the Foot & Ankle Ability Measure (FAAM) showed improved ability in activities of daily living (r = 0.58, P < 0.05) and sports (r = 0.69, P < 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.
format	article
author	Ryan Lubarsky, BA Beth Gusenoff, DPM Jeffrey A. Gusenoff, MD
author_facet	Ryan Lubarsky, BA Beth Gusenoff, DPM Jeffrey A. Gusenoff, MD
author_sort	Ryan Lubarsky, BA
title	Prospective Cohort Validation Study of a Novel Foot Offloading Device
title_short	Prospective Cohort Validation Study of a Novel Foot Offloading Device
title_full	Prospective Cohort Validation Study of a Novel Foot Offloading Device
title_fullStr	Prospective Cohort Validation Study of a Novel Foot Offloading Device
title_full_unstemmed	Prospective Cohort Validation Study of a Novel Foot Offloading Device
title_sort	prospective cohort validation study of a novel foot offloading device
publisher	Wolters Kluwer
publishDate	2021
url	https://doaj.org/article/79eb12d258e94cd9aa0f3f6f44cfcdb1
work_keys_str_mv	AT ryanlubarskyba prospectivecohortvalidationstudyofanovelfootoffloadingdevice AT bethgusenoffdpm prospectivecohortvalidationstudyofanovelfootoffloadingdevice AT jeffreyagusenoffmd prospectivecohortvalidationstudyofanovelfootoffloadingdevice
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Prospective Cohort Validation Study of a Novel Foot Offloading Device

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