Cargando…
A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers
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 int...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9927907/ https://www.ncbi.nlm.nih.gov/pubmed/36054243 http://dx.doi.org/10.1111/iwj.13932 |
_version_ | 1784888540484599808 |
---|---|
author | Armstrong, David G. Orgill, Dennis P. Glat, Paul M. Galiano, Robert D. Rasor, Zachary L Isaac, Adam Carter, Marissa Zelen, Charles M. |
author_facet | Armstrong, David G. Orgill, Dennis P. Glat, Paul M. Galiano, Robert D. Rasor, Zachary L Isaac, Adam Carter, Marissa Zelen, Charles M. |
author_sort | Armstrong, David G. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9927907 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-99279072023-02-16 A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers Armstrong, David G. Orgill, Dennis P. Glat, Paul M. Galiano, Robert D. Rasor, Zachary L Isaac, Adam Carter, Marissa Zelen, Charles M. Int Wound J Original Articles 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. Blackwell Publishing Ltd 2022-08-24 /pmc/articles/PMC9927907/ /pubmed/36054243 http://dx.doi.org/10.1111/iwj.13932 Text en © 2022 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Armstrong, David G. Orgill, Dennis P. Glat, Paul M. Galiano, Robert D. Rasor, Zachary L Isaac, Adam Carter, Marissa Zelen, Charles M. A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers |
title | A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers |
title_full | A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers |
title_fullStr | A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers |
title_full_unstemmed | A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers |
title_short | A single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers |
title_sort | single arm prospective feasibility study evaluating wound closure with a unique wearable device that provides intermittent plantar compression and offloading in the treatment of non‐healing diabetic foot ulcers |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9927907/ https://www.ncbi.nlm.nih.gov/pubmed/36054243 http://dx.doi.org/10.1111/iwj.13932 |
work_keys_str_mv | AT armstrongdavidg asinglearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT orgilldennisp asinglearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT glatpaulm asinglearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT galianorobertd asinglearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT rasorzacharyl asinglearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT isaacadam asinglearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT cartermarissa asinglearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT zelencharlesm asinglearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT armstrongdavidg singlearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT orgilldennisp singlearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT glatpaulm singlearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT galianorobertd singlearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT rasorzacharyl singlearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT isaacadam singlearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT cartermarissa singlearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers AT zelencharlesm singlearmprospectivefeasibilitystudyevaluatingwoundclosurewithauniquewearabledevicethatprovidesintermittentplantarcompressionandoffloadinginthetreatmentofnonhealingdiabeticfootulcers |