UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048978
Receipt number R000055800
Scientific Title A study of three-dimensional distribution of blood vessels in keloids using photoacoustic imaging
Date of disclosure of the study information 2022/11/01
Last modified on 2025/01/24 18:37:11

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Basic information

Public title

A study of three-dimensional distribution of blood vessels in keloids using photoacoustic imaging

Acronym

A study of three-dimensional distribution of blood vessels in keloids using photoacoustic imaging

Scientific Title

A study of three-dimensional distribution of blood vessels in keloids using photoacoustic imaging

Scientific Title:Acronym

A study of three-dimensional distribution of blood vessels in keloids using photoacoustic imaging

Region

Japan


Condition

Condition

Keloid

Classification by specialty

Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the association between conservative treatments and vasculatures in keloid using photoacoustic imaging

Basic objectives2

Others

Basic objectives -Others

To compare vasucular distribution in keloid before and after conservative treatments

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Morphological changes of vessels in keloid after conservative treatments

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Photoacoustic imaging examination

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who have been diagnosed with keloid of the trunk and limbs and indicated for conservative treatment
2. Patients who aged over 20 years and older at the time of informed consent
3. Patients who have agreed to participate in this study from their own free will with document consents

Key exclusion criteria

1. Pregnant and lactating patients
2. Patients who takes photosensitizer for photodynamic therapy
3. Patients with a cardiac pacemaker
4. Patients with greater than or equal to class 4 (Patients with severe systemic disease that is a constant threat to life)
in ASA-PS (American Society of Anaesthesiologists physical status classification)
5. People who have any following complications
Infections of the evaluation region
Neurological diseases and orthopedic disorders in which it is impossible to keep sitting or standing position
6. Patients who are judged ineligible to enroll into this clinical study by the investigator or the sub-investigators due to communication difficulty, limitations in taking examination position and other reasons.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Susumu
Middle name
Last name Saito

Organization

Graduate School of Medicine Kyoto University

Division name

Plastic and Reconstructive Surgery

Zip code

606-8507

Address

54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City

TEL

075-751-3613

Email

prs@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Aiko
Middle name
Last name Makino

Organization

Graduate School of Medicine Kyoto University

Division name

Plastic and Reconstructive Surgery

Zip code

606-8507

Address

54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City

TEL

075-751-3613

Homepage URL


Email

prs@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Graduate School of Medicine Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Luxonus Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Hospital Ethics Committe

Address

Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan

Tel

0757534680

Email

ethcom@kuhp.kyoto-u.ac.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



Other administrative information

Date of disclosure of the study information

2022 Year 11 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

Completed

Date of protocol fixation

2022 Year 08 Month 23 Day

Date of IRB

2022 Year 11 Month 02 Day

Anticipated trial start date

2022 Year 11 Month 02 Day

Last follow-up date

2024 Year 03 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

2022 Year 09 Month 20 Day

Last modified on

2025 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055800