PMID- 34950800
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211225
IS  - 2434-0790 (Electronic)
IS  - 2434-0790 (Linking)
VI  - 3
IP  - 12
DP  - 2021 Dec 10
TI  - 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.
PG  - 737-741
LID - 10.1253/circrep.CR-21-0097 [doi]
AB  - 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.
CI  - Copyright (c) 2021, THE JAPANESE CIRCULATION SOCIETY.
FAU - Sato, Yusuke
AU  - Sato Y
AD  - Cardiovascular Center, Tokeidai Memorial Hospital Sapporo Japan.
FAU - Urasawa, Kazushi
AU  - Urasawa K
AD  - Cardiovascular Center, Tokeidai Memorial Hospital Sapporo Japan.
FAU - Morishita, Tetsuji
AU  - Morishita T
AD  - Department of Internal Medicine, Matsunami General Hospital Gifu Japan.
FAU - Tan, Michinao
AU  - Tan M
AD  - Cardiovascular Center, Tokeidai Memorial Hospital Sapporo Japan.
FAU - Hayakawa, Naoki
AU  - Hayakawa N
AD  - Department of Cardiology, Asahi General Hospital Asahi Japan.
FAU - Tokuda, Takahiro
AU  - Tokuda T
AD  - Department of Cardiology, Nagoya Heart Center Nagoya Japan.
FAU - Nakano, Akira
AU  - Nakano A
AD  - Department of Cardiology, Hikone Municipal Hospital Hikone Japan.
FAU - Miyazawa, Tsuyoshi
AU  - Miyazawa T
AD  - Department of Cardiology, Hikone Municipal Hospital Hikone Japan.
FAU - Shimooka, Yoshinori
AU  - Shimooka Y
AD  - Department of Cardiology, Megumino Hospital Eniwa Japan.
FAU - Minegishi, Yoshiki
AU  - Minegishi Y
AD  - Department of Plastic and Reconstructive Surgery, University of Fukui Hospital 
      Fukui Japan.
FAU - Dannoura, Yutaka
AU  - Dannoura Y
AD  - Department of Cardiology, Sapporo City General Hospital Sapporo Japan.
FAU - Ikeda, Hiroyuki
AU  - Ikeda H
AD  - Department of Cardiology, Sugita Genpaku Memorial Obama Municipal Hospital Obama 
      Japan.
FAU - Hayashi, Taichi
AU  - Hayashi T
AD  - Cardiovascular Center, Tokeidai Memorial Hospital Sapporo Japan.
FAU - Miwa, Takashi
AU  - Miwa T
AD  - Cardiovascular Center, Tokeidai Memorial Hospital Sapporo Japan.
FAU - Hieda, Shohei
AU  - Hieda S
AD  - Cardiovascular Center, Tokeidai Memorial Hospital Sapporo Japan.
LA  - eng
PT  - Journal Article
DEP - 20211020
PL  - Japan
TA  - Circ Rep
JT  - Circulation reports
JID - 101746642
PMC - PMC8651475
OTO - NOTNLM
OT  - Chronic limb-threatening ischemia
OT  - Endovascular treatment
OT  - Hyperbaric oxygen therapy
OT  - Peripheral artery disease
OT  - Randomized controlled trial
COIS- None declared.
EDAT- 2021/12/25 06:00
MHDA- 2021/12/25 06:01
PMCR- 2021/10/20
CRDT- 2021/12/24 05:55
PHST- 2021/07/13 00:00 [received]
PHST- 2021/09/18 00:00 [revised]
PHST- 2021/09/21 00:00 [accepted]
PHST- 2021/12/24 05:55 [entrez]
PHST- 2021/12/25 06:00 [pubmed]
PHST- 2021/12/25 06:01 [medline]
PHST- 2021/10/20 00:00 [pmc-release]
AID - 10.1253/circrep.CR-21-0097 [doi]
PST - epublish
SO  - Circ Rep. 2021 Oct 20;3(12):737-741. doi: 10.1253/circrep.CR-21-0097. eCollection 
      2021 Dec 10.