UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042839 |
|---|---|
| Receipt number | 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 | 2022/09/14 22:32:37 |
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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
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
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
toppy1363@gmail.com
Sponsor or person
Institute
Tokeidai memorial hospital, Cardiovascular center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048871
