UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016584
Receipt number R000019240
Scientific Title Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO)
Date of disclosure of the study information 2015/02/20
Last modified on 2017/12/23 15:23:11

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Basic information

Public title

Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO)

Acronym

Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO)

Scientific Title

Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO)

Scientific Title:Acronym

Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO)

Region

Japan


Condition

Condition

Peripheral arterial disease with wound and/or ulcer in the lower limb

Classification by specialty

Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of DF Thermo therapy in the severe ischemic limb ASO patients who underwent bypass revascularization surgery, and with wound and/or ulcer in the lower limb.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate of diminishment of wound and/or ulcer by DF thermo therapy

Key secondary outcomes

SPP, ABI, ultrasonography of lower limb, VEGF, fibrinogen, IgM, LDL-cholesterol, HDL-cholesterol, total cholesterol, DESIGN-R, Vascu QOL


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

DF Thermo group (Patients underwent DF Thermo therapy)
Study period; 35 weeks at the maximum

Interventions/Control_2


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

86 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who fulfill all of the following conditions are included.
1) Age is over 20 years and less than 86 years, regardless of sex
2) Diagnosed as ASO with Fontaine Grade IV
3) With wound and/or ulcer in the lower limb and underwent bypass revascularization surgery
4) Patients who can give written informed consent by themselves or by their surrogates, understanding the objective and content of the study

Key exclusion criteria

Patients who fulfill any of the following conditions are excluded.
1) Pregnancy, breast-feeding, with possibility of pregnancy, or who wish to become pregnant during the study period
2) Patients who are considered as inadequate by the physician in charge

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinji Togashi

Organization

Shonai Amarume Hospital

Division name

Plastic and reconstructive surgery

Zip code


Address

1-1-1 Shoyo, Shonai-town, Hogashitagawa, Yamagata

TEL

0234-43-3434

Email

stoga@amarume-hp.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinji Togashi

Organization

Shonai Amarume Hospital

Division name

Plastic and reconstructive surgery

Zip code


Address

1-1-1 Shoyo, Shonai-town, Hogashitagawa, Yamagata

TEL

0234-43-3434

Homepage URL


Email

stoga@amarume-hp.jp


Sponsor or person

Institute

Shonai Amarume Hospital

Institute

Department

Personal name



Funding Source

Organization

Kawasumi Laboratories, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 20 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

Terminated

Date of protocol fixation

2015 Year 01 Month 05 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 19 Day

Last modified on

2017 Year 12 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019240


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name