Multicentre study of disposable warmer for raynaud's phenomenon

The single-arm multicentre study using heating device by applying iron oxidation for Raynaud's phenomenon caused by systemic sclerosis - HOCA study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052190086

Enrollment

Registered

2019-12-23

Start date

2019-12-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis Scleroderma, Raynaud's phenomenon

Interventions

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. Follo

warmer, heat pack, heat pad, disposable

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactAkane Watanabe

Osaka University Hospital

a.watanabe@imed3.med.osaka-u.ac.jp+81-6-6105-5710

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026