UMIN-CTR Clinical Trial

Basic information
Public title	Combined Treatment with Hyperbaric Oxygen Therapy and Endovascular therapy FOr Patients with ChrOnic Limb-Threatening Ischemia
Acronym	HOTFOOT
Scientific Title	Combined Treatment with Hyperbaric Oxygen Therapy and Endovascular therapy FOr Patients with ChrOnic Limb-Threatening Ischemia -Multicenter Randomized Controlled Trial-
Scientific Title:Acronym	HOTFOOT
Region	Japan

Condition
Condition	Chronic limb-threatening ischemia Arteriosclerosis obliterans
Classification by specialty	Cardiology Vascular surgery Radiology Cardiovascular surgery Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to evaluate the effect of combined treatment with hyperbaric oxygen therapy and endovascular therapy on limb outcomes in patients with chronic limb-threatening ischemia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Time to wound healing in 6 months
Key secondary outcomes	1.Wound healing rate at 6 months 2.Major lower limb amputation rate at 6 months 3.Amputation free survival at 6 months 4.The rate of re-intervention at 6 months

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Patients received combined treatment with hyperbaric oxygen therapy(HBOT) and endovascular treatment (Combined treatment group) A session of HBOT was performed with a chamber pressurized at 2.0 to 2.5 atmospheres absolute and 100% oxygen had been breathed for 90 min. HBOT is scheduled until wound healing has been achieved or until a maximum of 30 sessions has been reached.
Interventions/Control_2	Patients received endovascular treatment (Endovascular treatment group)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic limb-threatening ischemia having 1. toe pressure <30 mm Hg, or SPP <30 mm Hg or TcPO2 <30 mm Hg 2. ischemic ulcer or gangrene, namely Fontaine stage IV, Rutherford classification 5 or 6 3. primary success in endovascular treatment.
Key exclusion criteria	1. Patients during pregnancy or breastfeeding 2. Contraindicated patients with hyperbaric oxygen therapy 3. Patients scheduled to undergo LDL apheresis 4. Patients with severe infection (namely, foot infection grade 3 in the Wound, Ischemia, and foot Infection [WIfI] classification)
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Kazushi Middle name Last name Urasawa
Organization	Tokeidai memorial hospital
Division name	Cardiovascular center
Zip code	060-0031
Address	2-3 North-1, East 1, Chuo-Ku Sapporo, Hokkaido 060-0031, Japan
TEL	0112511221
Email	k-urasawa@tokeidaihosp.or.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Sato
Organization	Tokeidai memorial hospital
Division name	Cardiovascular center
Zip code	0600031
Address	2-3 North-1, East 1, Chuo-Ku Sapporo, Hokkaido 060-0031, Japan
TEL	0112511221
Homepage URL
Email	toppy1363@gmail.com

Sponsor
Institute	Tokeidai memorial hospital, Cardiovascular center
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokeida Memorial Hosptal Clinical Research Ethics Committee
Address	2-3 North-1, East 1, Chuo-Ku Sapporo, Hokkaido 060-0031, Japan
Tel	011-251-1221
Email	kojima-pt@tokeidaihosp.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国保旭中央病院（千葉）、王子総合病院（北海道）、彦根市立病院（滋賀）、恵み野病院（北海道）、名古屋ハートセンター（愛知）、坂総合病院（宮城）、市立札幌病院（北海道）、福井大学病院（福井）、杉田玄白記念公立小浜病院(福井）、天陽会中央病院（鹿児島）

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2020 Year 11 Month 01 Day
Date of IRB	2020 Year 11 Month 19 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2027 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 24 Day
Last modified on	2022 Year 09 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048871