Multicentre study of disposable warmer for raynaud's phenomenon

JRCT ID: jRCTs052190086

Registered date:23/12/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Systemic Sclerosis
• Date of first enrollment: 26/12/2019
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Subjects are requested to wear the warmers on their upper arms for 2 weeks. The time of wearing the warmers is about 6-12 hours a day, and they are prohibited to wear the warmers while sleeping. Following a next 2 week-interval without wearing warmers, they wear the warmers again for 2weeks.

Outcome(s)

Primary Outcome

Differences between the Rayaud's condition scores (RCSs) in the period of wearing the tested device and the RCSs in the period of not wearing.
Difference of RCS (delta RCS) is defined as difference between "average of RCSs in the period of wearing the device" and "average of RCSs in the period of not wearing the device".

Secondary Outcome

1.Differences between the frequency of RP attacks in the period of wearing the tested device and
that of not wearing.
2.Differences between the duration of RP attack in the period of wearing the tested device and that of not wearing.
3.Correlation between average temperature and RCS
4.Correlation between average time of wearing the device and delta RCS
For safety assesment:
1. Adverse event occurred in the period of wearing the tested device and not wearing.
2.Treatment related adverse event occurred in the period of wearing the tested device.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1. Patients over 20 years old and under 90 years old.
2. Patients who have Raynaud's phenomenon(RP) and meet the 2013 Classification Criteria for Systemic Sclerosis (ACR/EAULAR) .
3. Patients who give written informed consent.

Exclude criteria

1. Chronic febrile disease including infectious disease
2. Diabetes mellitus
3. Another skin disease except systemic sclerosis at the site of wearing the warmer
4. Incapable of taking off the warmer by themselves
5. Peripheral neuropathy of upper extremities or past medical history of that
6. Vascular shunt on the arm for hemodialysis
7. Others (judged as ineligible by the responsible researcher)

Related Information

• Primary Sponsor: Shima Yoshihito
• Source(s) of Monetary Support: Kiribai Chemical Co., Ltd.,KOBAYASHI Pharmaceutical Co., Ltd.