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Combined Treatment With Hyperbaric Oxygen Therapy and Endovascular Therapy for Patients With Chronic Limb-Threatening Ischemia ― Study Protocol for the HOTFOOT Multicenter Randomized Controlled Trial ―
Background: Hyperbaric oxygen therapy (HBOT) is regarded as one of the therapeutic options added to standard care to improve lower-limb outcomes in patients with chronic limb-threatening ischemia (CLTI). However, the current guidelines specify that HBOT should not be offered instead of revasculariza...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The Japanese Circulation Society
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8651475/ https://www.ncbi.nlm.nih.gov/pubmed/34950800 http://dx.doi.org/10.1253/circrep.CR-21-0097 |
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author | Sato, Yusuke Urasawa, Kazushi Morishita, Tetsuji Tan, Michinao Hayakawa, Naoki Tokuda, Takahiro Nakano, Akira Miyazawa, Tsuyoshi Shimooka, Yoshinori Minegishi, Yoshiki Dannoura, Yutaka Ikeda, Hiroyuki Hayashi, Taichi Miwa, Takashi Hieda, Shohei |
author_facet | Sato, Yusuke Urasawa, Kazushi Morishita, Tetsuji Tan, Michinao Hayakawa, Naoki Tokuda, Takahiro Nakano, Akira Miyazawa, Tsuyoshi Shimooka, Yoshinori Minegishi, Yoshiki Dannoura, Yutaka Ikeda, Hiroyuki Hayashi, Taichi Miwa, Takashi Hieda, Shohei |
author_sort | Sato, Yusuke |
collection | PubMed |
description | Background: Hyperbaric oxygen therapy (HBOT) is regarded as one of the therapeutic options added to standard care to improve lower-limb outcomes in patients with chronic limb-threatening ischemia (CLTI). However, the current guidelines specify that HBOT should not be offered instead of revascularization to prevent limb loss in CLTI patients. The aim of the HOTFOOT study is to examine the impact of HBOT on wound healing in CLTI patients after successful endovascular therapy (EVT). Methods and Results: The HOTFOOT study is a multicenter prospective randomized open blinded-endpoint trial that is to be conducted at 10 trial centers in Japan between February 2021 and February 2022. This study will enroll 140 patients with CLTI receiving successful EVT. Eligible participants will be allocated 1 : 1 to either the EVT+HBOT or EVT group; participants in the EVT+HBOT group will receive 30 HBOT sessions. The primary outcome is the time to complete wound healing over the 6-month follow-up. Secondary outcomes during the 6-month follow-up are the proportion of patients who achieved complete wound healing, freedom from major lower-limb amputation, amputation-free survival, and freedom from target lesion reintervention. Conclusions: This study is expects to assess whether HBOT, in combination with successful EVT, can improve lower-limb outcomes in CLTI patients. |
format | Online Article Text |
id | pubmed-8651475 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | The Japanese Circulation Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-86514752021-12-22 Combined Treatment With Hyperbaric Oxygen Therapy and Endovascular Therapy for Patients With Chronic Limb-Threatening Ischemia ― Study Protocol for the HOTFOOT Multicenter Randomized Controlled Trial ― Sato, Yusuke Urasawa, Kazushi Morishita, Tetsuji Tan, Michinao Hayakawa, Naoki Tokuda, Takahiro Nakano, Akira Miyazawa, Tsuyoshi Shimooka, Yoshinori Minegishi, Yoshiki Dannoura, Yutaka Ikeda, Hiroyuki Hayashi, Taichi Miwa, Takashi Hieda, Shohei Circ Rep Protocol Paper Background: Hyperbaric oxygen therapy (HBOT) is regarded as one of the therapeutic options added to standard care to improve lower-limb outcomes in patients with chronic limb-threatening ischemia (CLTI). However, the current guidelines specify that HBOT should not be offered instead of revascularization to prevent limb loss in CLTI patients. The aim of the HOTFOOT study is to examine the impact of HBOT on wound healing in CLTI patients after successful endovascular therapy (EVT). Methods and Results: The HOTFOOT study is a multicenter prospective randomized open blinded-endpoint trial that is to be conducted at 10 trial centers in Japan between February 2021 and February 2022. This study will enroll 140 patients with CLTI receiving successful EVT. Eligible participants will be allocated 1 : 1 to either the EVT+HBOT or EVT group; participants in the EVT+HBOT group will receive 30 HBOT sessions. The primary outcome is the time to complete wound healing over the 6-month follow-up. Secondary outcomes during the 6-month follow-up are the proportion of patients who achieved complete wound healing, freedom from major lower-limb amputation, amputation-free survival, and freedom from target lesion reintervention. Conclusions: This study is expects to assess whether HBOT, in combination with successful EVT, can improve lower-limb outcomes in CLTI patients. The Japanese Circulation Society 2021-10-20 /pmc/articles/PMC8651475/ /pubmed/34950800 http://dx.doi.org/10.1253/circrep.CR-21-0097 Text en Copyright © 2021, THE JAPANESE CIRCULATION SOCIETY https://creativecommons.org/licenses/by-nc-nd/4.0/This article is licensed under a Creative Commons [Attribution-NonCommercial-NoDerivatives 4.0 International] license. |
spellingShingle | Protocol Paper Sato, Yusuke Urasawa, Kazushi Morishita, Tetsuji Tan, Michinao Hayakawa, Naoki Tokuda, Takahiro Nakano, Akira Miyazawa, Tsuyoshi Shimooka, Yoshinori Minegishi, Yoshiki Dannoura, Yutaka Ikeda, Hiroyuki Hayashi, Taichi Miwa, Takashi Hieda, Shohei Combined Treatment With Hyperbaric Oxygen Therapy and Endovascular Therapy for Patients With Chronic Limb-Threatening Ischemia ― Study Protocol for the HOTFOOT Multicenter Randomized Controlled Trial ― |
title | Combined Treatment With Hyperbaric Oxygen Therapy and Endovascular Therapy for Patients With Chronic Limb-Threatening Ischemia ― Study Protocol for the HOTFOOT Multicenter Randomized Controlled Trial ― |
title_full | Combined Treatment With Hyperbaric Oxygen Therapy and Endovascular Therapy for Patients With Chronic Limb-Threatening Ischemia ― Study Protocol for the HOTFOOT Multicenter Randomized Controlled Trial ― |
title_fullStr | Combined Treatment With Hyperbaric Oxygen Therapy and Endovascular Therapy for Patients With Chronic Limb-Threatening Ischemia ― Study Protocol for the HOTFOOT Multicenter Randomized Controlled Trial ― |
title_full_unstemmed | Combined Treatment With Hyperbaric Oxygen Therapy and Endovascular Therapy for Patients With Chronic Limb-Threatening Ischemia ― Study Protocol for the HOTFOOT Multicenter Randomized Controlled Trial ― |
title_short | Combined Treatment With Hyperbaric Oxygen Therapy and Endovascular Therapy for Patients With Chronic Limb-Threatening Ischemia ― Study Protocol for the HOTFOOT Multicenter Randomized Controlled Trial ― |
title_sort | combined treatment with hyperbaric oxygen therapy and endovascular therapy for patients with chronic limb-threatening ischemia ― study protocol for the hotfoot multicenter randomized controlled trial ― |
topic | Protocol Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8651475/ https://www.ncbi.nlm.nih.gov/pubmed/34950800 http://dx.doi.org/10.1253/circrep.CR-21-0097 |
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