NCT06127992

Non-invasive Diagnosis of Cold Urticaria

Photoplethysmography for Non-invasive Diagnosis of Cold Urticaria

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: City Clinical Hospital No.52 of Moscow Healthcare Department · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The investigators subjected 63 patients (39 with typical Cold urticaria and 24 with atypical Cold urticaria ) and 15 healthy controls to TempTest® cold stimulation tests and critical temperature threshold assessments. Blood microcirculation photoplethysmography measurements were performed 5 min before and 10 min after the ice cube on the volar forearm.

Conditions

• Urticaria Cold

Interventions

Type	Name	Description
DEVICE	Cold stimulation tests / critical temperature threshold	ICT was performed following a standard protocol. Briefly, a melting ice cube in thin plastic bag was placed on the volar surface of the patient forearm for 5 min, with macroscopic assessment of the test site 10 min later. TempTest® CSTs were done with TempTest® 4.0 (Courage \& Khazaka, Cologne, Germany), which has a single Peltier element (length: 350 mm, width: 2 mm) that provides a continuous temperature gradient from 4°C to 44°C. The use of TempTest® allows for reproducible and standardized cold (and heat) provocation tests and the identification of CTTs. TempTest® CST results were also assessed 10 min after the end of cold exposure.

Timeline

• Start date: 2023-05-12
• Primary completion: 2023-11-27
• Completion: 2023-11-27
• First posted: 2023-11-13
• Last updated: 2023-11-13

Locations

1 site across 1 country: Russia