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

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 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

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

Value
https://center6.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