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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035332
Enrollment
20
Registered
2018-12-21
Start date
2019-01-11
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

Interventions

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

Sponsors

Osaka University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

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

Countries

Japan

Contacts

Public ContactAkane Watanabe

Osaka University Graduate School of Medicine Thermo-therapeutics for Vascular dysfunction

a.watanabe@imed3.med.osaka-u.ac.jp0661055710

Outcome results

None listed

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