Assessment of Vasomotion of People With Idiopathic Chilblains

Thermoregulation Clinical Trial

Official title:

Assessment of Vasomotion of People With Idiopathic Chilblains

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06237517
• Other study ID #: 1888
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: March 2024
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chilblains, also known as perniosis, is a non-freezing cold injury causing painful inflammatory skin lesions. Chilblains typically affect the dorsal feet or hands, causing inflammatory skin lesions that are often painful, and their pathogenesis remains only partly understood. To improve diagnosis and management, it is vital to focus entirely on chilblains and consider the patient-related and environmental factors that characterize this disorder. Because of this, it's critical to investigate the thermoregulatory function, of individuals with idiopathic chilblains while they are exposed to various environmental conditions (cold and neutral environments).

Description:

The participants will visit the laboratory three times. The environmental scenarios were randomly allocated for each participant.

The three different environments will be as follows:

1. Thermoneutral environment 22-24°C and 40-50% relative humidity for 15 minutes.

2. Thermoneutral environment of 22-24°C and 40-50% relative humidity, the temperature within the chamber was decreased by 4 degrees every 20 minutes.

3. Thermoneutral environment of 22-24°C and 40-50% relative humidity, the temperature within the chamber was decreased by 4 degrees every 20 minutes. After 80 minutes (the chamber's temperature will be 10°C and 40-50% relative humidity), the investigators increased the chamber temperature to 22-24 °C and 40-55% relative humidity, and the participants remained in the same sitting position for 20 minutes.

All participants had antinuclear antibodies blood testing for a suspected autoimmune disease such as lupus, rheumatoid arthritis, or scleroderma. Participants were provided blood (C-reactive protein and serum Cortisol) before, immediately after, and 24 hours after each trial and urine samples before and following the trials.

Anthropometric data [self-reported age, self-reported body stature, and body mass (DXA, Lunar, GE Healthcare Boston, Massachusetts, U.S.)] will be collected at the beginning of the first visit. Investigators recorded the medical history of all the participants. During the study, continuous heart rate and heart rate variability (Polar Team2. Polar Electro Oy, Kempele, Finland), core temperature (telemetric capsules BodyCap, Caen, France), mean skin temperature (wireless thermistors iButtons type DS1921H, Maxim/Dallas Semiconductor Corp., USA), finger temperature, skin blood flow (laser Doppler flow-meter PeriFlux System 5010, Stockholm, Sweden), and tissue oxygenation changes (Near-Infrared Spectroscopy, PortaLite mini, Artinis Medical Systems, Zetten, Netherlands) will be collected. Skin temperature data collected from seven sites (forehead, arm, thigh, hand, foot, tibialis anterior, navel) and will be expressed as mean skin temperature according to the formula of Hardy/Bubois (Tsk = [0.7 (forehead) + 0.14 (arm) + 0.05 (hand) + 0.07 (foot) + 0.13 (tibialis anterior) + 0.19 (thigh) + 0.35 (navel)]. Hydration status was assessed using a handheld refractometer (ATAGO Ltd, Tokyo, Japan) and determined as either euhydrated (USG < 1.020) or dehydrated (USG ≥ 1.020) according to the current guidelines. Questionnaires (thermal sensation scale: -3 = cold; +3 = hot) assessed participants' thermal comfort/sensation and pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy individuals with and without idiopathic chilblains.

Exclusion Criteria:

• Non-healthy individuals or any underlying connective tissue disorders (particularly:

Raynaud syndrome/phenomenon, Systemic Lupus Erythematosus, Scleroderma)

Related Conditions & MeSH terms

• Chilblains
• Thermoregulation

Intervention

Behavioral:
• Assessment of Vasomotion of People With Idiopathic Chilblains
Investigation of vasomotion of people with and without idiopathic chilblains

Locations

Country	Name	City	State
Greece	FAME Lab, Department of Exercise Science, University of Thessaly Tríkala, Thessaly, Greece, 42100	Trikala

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Heart rate were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland	1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
Primary	Heart rate variability	Heart rate variability were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland	1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
Primary	Skin blood flow	Skin blood flow was measured throughout the entire protocol with a laser Doppler flowmeter ((PeriFlux System 5010, function unit; Perimed, Stockholm, Sweden, PeriFlux 4000, Perimed, Stockholm, Sweden) at right and left index finger and right and left index toe.	1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
Primary	Skin temperature	Skin temperature (forehead, arm, thigh, hand, foot, tibialis anterior, navel) was continuously monitored using iButton sensors type DS1921 H, Maxim/Dallas Semiconductor Corp., USA.	1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
Primary	Finger temperature	Finger temperature were monitored throughout the trial using a data logger interfacing with a computer to allow for their continuous monitoring by the investigators.	1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
Primary	Hemoglobin oxygen saturation in a localized tissue (foot)	Hemoglobin oxygen saturation in a localized tissue were monitored throughout the trial at 10Hz and data duration 919.2s using (Near-Infrared Spectroscopy, PortaLite mini, Artinis Medical Systems, Zetten, Netherlands).	1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
Primary	Body core temperature	Core body temperature was assessed using telemetric capsules (e-Celsius, BodyCap, Caen, France) which were ingested by the participants 2 hours before of each trial.	1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
Primary	Thermal comfort	Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).	Change from baseline thermal comfort at 20th, 40th, 60th, and 80th minute (for trial without warming - 1 hour and 35 minutes), and at 20th, 40th, 60th, 80th, and 100th minute (for trial with warming - 1 hour and 55 minutes)
Primary	Thermal sensation	Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)	Change from baseline thermal sensation at 20th, 40th, 60th, and 80th minute (for trial without warming - 1 hour and 35 minutes), and at 20th, 40th, 60th, 80th, and 100th minute (for trial with warming - 1 hour and 55 minutes)
Primary	Blood samples	Participants were provided blood samples (C-reactive protein and Cortisol).	Participants were given blood samples at baseline, at 1 hour and 35 minutes (trial without rewarming)/1 hour and 55 minutes (trial with rewarming), and 24 hours after each trial.
Primary	Urine sample	Participants were provided urine samples (urine specific gravity)	Participants were given urine samples at baseline, at 1 hour and 35 minutes (trial without rewarming)/1 hour and 55 minutes (trial with rewarming), and 24 hours after each trial.