UMIN-CTR Clinical Trial

Public title

Clinical study of Usability and Safety under the use of disposable warmer on each site for the patients with Upper limb Circulation disorder

Acronym

US-UCir study

Scientific Title

Clinical study of Usability and Safety under the use of disposable warmer on each site for the patients with Upper limb Circulation disorder

Scientific Title:Acronym

US-UCir study

Region

Japan

Condition

systemic sclerosis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to explore the safety, the influence to daily living, the subjective symptoms, and the influence to the hand temperture and peripheral blood flow when the patients with systemic sclerosis who present Ranaud's phenomenon use disposable hand warmers on their neck, elbows, or wrists.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Visual analog scale data of subjective evaluation against Raynaud's phenomenon

Key secondary outcomes

Study type

Interventional

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

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Systemic sclerosis patients with impaired hand blood circulation wear a disposable warmer on the neck, elbow and wrist for 1 week, respectively.

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Patients who are visiting to Osaka University Medical School hospital.
2. Over 20 years old and under 80 years.
3. Systemic scleroderma patients who satisfy the scleroderma diagnostic criteria (1980) of American Society of Rheumatology.
4. Patients who can agree in sentence to the document and verbal explanation.
5. Patients satisfying the above criteria and judged appropriate by the researcher.

Key exclusion criteria

1.Patients complicated with chronic diseases and infectious diseases accompanied by fever.
2.Patients with diabetes mellitus.
3.Patients with skin disorder other than scleroderma in the worn area of the body.
4.Patients who can not detach / attach the device by herself.
5.Patients with peripheral neuropathy or patients who have been diagnosed with peripheral neuropathy (eg, cervical spondylosis, carpal tunnel syndrome).
6.Patients who are judged inappropriate by the researcher.

Target sample size

20

Name of lead principal investigator

1st name	Yoshihito
Middle name
Last name	Shima

Organization

Osaka University Graduate School of Medicine

Division name

Thermo-therapeutics for Vascular dysfunction

Zip code

565-0871

Address

1-3 Yamada-oka, Suita city, Osaka565-0871, Japan

TEL

06-6105-5710

Email

ryanjin@imed3.med.osaka-u.ac.jp

Name of contact person

1st name	Akane
Middle name
Last name	Watanabe

Organization

Osaka University Graduate School of Medicine

Division name

Thermo-therapeutics for Vascular dysfunction

Zip code

565-0871

Address

1-3 Yamada-oka, Suita city, Osaka565-0871, Japan

TEL

0661055710

Homepage URL

Email

a.watanabe@imed3.med.osaka-u.ac.jp

Institute

Osaka University

Institute

Department

Personal name

Organization

Joint research project of Osaka University with Kiribai Chemical Co.,Ltd. and Kobayashi Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JP

Co-sponsor

Name of secondary funder(s)

Organization

Osaka University Clinical Research Review Committee

Address

2-2Yamadaoka, Suita, Osaka, Japan

Tel

0662108296

Email

handai-nintei@hp-crc.med.osaka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

12

Month

21

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000040206&flwp_key=10091O479RE

Publication of results

Published

URL related to results and publications

https://academic.oup.com/mr/article/32/2/351/6363900?login=true

Number of participants that the trial has enrolled

16

Results

The neck, elbow, and wrist were heated in random order with the same heat level. The visual analogue scale (VAS) of Raynaud's phenomenon in the hand decreased when the neck and elbow were heated. No decrease in VAS was observed during wrist heating, which was closer to the fingers.

Results date posted

2023

Year

06

Month

27

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

There were 16 entry patients, but violation of the exclusion criteria was found on two participants.14 patients were included in the analysis group.
The mean age of the subjects was 60 years, the mean disease duration was 13 years, The seven had diffuse cutaneous SSc, and 7 had limited SSc. Ten were female patients and four were patients.
The analysis group included one subject with pulmonary hypertension, and one with scleroderma kidney.

Participant flow

Written consent was obtained after oral and written explanations. On the same day, the participants were handed diaries, disposable warmers, and special holders for the wamers, and were instructed to use them from the designated date.
After one-week pre-observation period, the neck, elbow, and wrist were heated in random order with a one-week gap between each heating period.
Each subject completed the study if there were no changes at the warmer site at the visit on the day following the seventh day of heating at the third site.

Adverse events

Five events of minor burn were observed; three occurred after the neck heating and the two occurred after the elbow heating. All of them were epidermal and were cured.
Eczema was observed in one patient after neck heating. This may caused by increased sweating.
Two patients showed fingertip changes (epidermal peeling and laceration) during the interval period wihout any heating.
One patient experienced parotid swelling during the pre-heating observation period.

Outcome measures

Visual analogue scale (VAS) for Raynaud's phenomenon.
Finger skin temperature measeured by thermography.
Digital finger tissue blood flow measured by Laser Speckle Contrast Analysis (LASCA).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

12

Month

12

Day

Date of IRB

2018

Year

12

Month

21

Day

Anticipated trial start date

2019

Year

01

Month

11

Day

Last follow-up date

2019

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

12

Month

21

Day

Last modified on

2023

Year

06

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040206