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Non-invasive Diagnosis of Cold Urticaria

Photoplethysmography for Non-invasive Diagnosis of Cold Urticaria

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06127992
Enrollment
78
Registered
2023-11-13
Start date
2023-05-12
Completion date
2023-11-27
Last updated
2023-11-13

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

Conditions

Urticaria Cold

Brief 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.

Interventions

DEVICECold 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.

Sponsors

City Clinical Hospital No.52 of Moscow Healthcare Department
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Cold urticaria

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Photoplethysmography amplitude10 min after the end of cold exposureTo compute the blood flow signal, we subtracted slowly time-varying background and frequency components out of the cardiovascular-related range of 0.3-7 Hz. The resulting well-matched, noise-free and intensity-corrected blood flow images are suited for PPG calculation by averaging the intensity pixel values of each frame. The PPG amplitude is proportional to the amount of arterial blood that reaches the visualized skin area and thus characterizes its blood perfusion. It is measured in arbitrary units (AU). We performed photoplethysmographic assessments of the volar forearm of all patients 5 minutes before and 10 minutes after the beginning and end of ice cube application.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026