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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042839
Receipt No. R000048871
Scientific Title Combined Treatment with Hyperbaric Oxygen Therapy and Endovascular therapy FOr Patients with ChrOnic Limb-Threatening Ischemia -Multicenter Randomized Controlled Trial-
Date of disclosure of the study information 2021/01/01
Last modified on 2021/06/24

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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
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)、板橋中央総合病院(東京)、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)

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
2023 Year 01 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
2021 Year 06 Month 24 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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