Clinical study optimizing temperature of disposable warmers for Raynaud's phenomenon

JRCT ID: jRCTs052240191

Registered date:21/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic sclerosis
• Date of first enrollment: 21/11/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Following a one-week of no-treatment observation period, study participants are instructed to insert the applied disposable warmers into holders antd place them on the both upper arms near the elbow for one week. This two-weeks' observation and intervention is considered as one period, and the same for the other two temperature range warmers, for a total of three cools. The order of application of the three temperature range disposable body warmers will be randomly selected from six options for each participant.

Outcome(s)

• Primary Outcome: The change in the average Raynaud Condition Score (RCS) recorded in the participants' diary between the warmer-applied period and non-warmer-applied period for each of the three temperature of the warmer.

Secondary Outcome

1. Number and frequency of Raynaud's phenomenon as recorded in the diary (times/day)
2. Total duration of Raynaud's phenomenon per day (minutes/day)
3. Number and frequency of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1.Patients attending Osaka University Hospital
2.20 years old or older and under 80 years old
3.Patients with systemic sclerosis who meet the classification criteria by the ACR/EULAR 2013 and have Raynaud's phenomenon.
4.Patients who have been fully informed of the study and who have given written consent of their own free wil.

Exclude criteria

1. Patients chronically febrile due to primary disease or comorbidities
2. Patients with Diabetes mellitus
3. Patients with another skin disease except systemic sclerosis at the site of wearing the warmer
4. Patients who are incapable of taking off the warmer by themselves
5. Patients with peripheral neuropathy of upper extremities or past medical history of that
6. Patients with vascular shunt on the arm for hemodialysis
7. Patients who are judged as ineligible by the responsible researcher for other reasons

Related Information

• Primary Sponsor: Shima Yoshihito
• Source(s) of Monetary Support: Kobayashi pharmaceutical Co,. Ltd.