Assessment of Vasomotion of People With Idiopathic Chilblains

NCT06237517 | Completed

• 1 other identifier: 1888
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chilblains; Perniosis; Thermoregulation

Keywords

Non-freezing cold injuries; Chilblains; Perniosis; Skin lesions; Vasomotion

Outcome Measures

Primary Outcomes (11)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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.

• 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.

Study Arms (6)

Progressive acclimation of healthy individuals with Idiopathic Chilblains

EXPERIMENTAL

Throughout the experiment, the participants remained seated in a sitting position. The trial began with the chamber's temperature at 22-24°C and 40-50% (relative humidity) for 20 minutes. After this period, the temperature within the chamber dropped by 4 degrees every 20 minutes. After 80 minutes, the temperature was maintained at 10°C and 40-50% (relative humidity) for 15 minutes, and an occlusion foot test for 15 minutes, and an occlusion foot test (5 minutes ''baseline'' phase, 5 minutes ''occlusion'' phase, and 5 minutes ''release'' phase) was performed to observe any hemodynamic changes in the foot. Participants provided blood and urine samples before and following the trial.

Behavioral: Assessment of Vasomotion of People With Idiopathic Chilblains

Progressive acclimation of healthy individuals with Idiopathic Chilblains (Rewarming Phase)

EXPERIMENTAL

Throughout the experiment, the participants remained seated in a sitting position. The trial began with the chamber's temperature at 22-24 °C and 40-50% relative humidity for 20 minutes. After this period, the temperature within the chamber dropped by 4 degrees every 20 minutes. After 80 minutes (the chamber's temperature was 10°C and 40-50%), a radiator heater was placed in front of the participants to increase the temperature of their extremities. Simultaneously, the investigators increased the temperature of the chamber to 22-24 °C and 40-55% relative humidity, and the participants remained in the same sitting position for 20 minutes. Following this period, an occlusion foot test was performed to observe any hemodynamic changes in the foot. The test consisted of a 5-minute ''baseline'' phase, a 5-minute ''occlusion'' phase, and a 5-minute ''release'' phase. Before and after the trial, participants provided blood and urine samples.

Behavioral: Assessment of Vasomotion of People With Idiopathic Chilblains

Progressive acclimation of healthy individuals without Idiopathic Chilblains

ACTIVE COMPARATOR

Throughout the experiment, the participants remained seated in a sitting position. The trial began with the chamber's temperature at 22-24°C and 40-50% (relative humidity) for 20 minutes. After this period, the temperature within the chamber dropped by 4 degrees every 20 minutes. After 80 minutes, the temperature was maintained at 10°C and 40-50% (relative humidity) for 15 minutes, and an occlusion foot test for 15 minutes, and an occlusion foot test (5 minutes ''baseline'' phase, 5 minutes ''occlusion'' phase, and 5 minutes ''release'' phase) was performed to observe any hemodynamic changes in the foot. Participants provided blood and urine samples before and following the trial.

Behavioral: Assessment of Vasomotion of People With Idiopathic Chilblains

Progressive acclimation of healthy individuals without Idiopathic Chilblains (Rewarming Phase)

ACTIVE COMPARATOR

Throughout the experiment, the participants remained seated in a sitting position. The trial began with the chamber's temperature at 22-24 °C and 40-50% relative humidity for 20 minutes. After this period, the temperature within the chamber dropped by 4 degrees every 20 minutes. After 80 minutes (the chamber's temperature was 10°C and 40-50%), a radiator heater was placed placed in front of the participants to raise the temperature of their extremities. Simultaneously, 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. Following this period, an occlusion foot test was performed to observe any hemodynamic changes in the foot. The test consisted of a 5-minute ''baseline'' phase, a 5-minute ''occlusion'' phase, and a 5-minute ''release'' phase. Before and after the trial, participants provided blood and urine samples.

Behavioral: Assessment of Vasomotion of People With Idiopathic Chilblains

Thermoneutral environment healthy participants with Idiopathic Chilblains (Baseline)

EXPERIMENTAL

Throughout the experiment, the participants remained seated in a sitting position. The trial began with the chamber's temperature at 22-24°C and 40-50% (relative humidity) for 20 minutes. After 20 minutes, the temperature was maintained at 22°C and 40-50% (relative humidity) for 15 minutes, and an occlusion foot test was conducted (5 minutes ''baseline'' phase, 5 minutes ''occlusion'' phase, and 5 minutes ''release'' phase), to observe any hemodynamic changes in the foot.

Behavioral: Assessment of Vasomotion of People With Idiopathic Chilblains

Thermoneutral environment healthy participants without Idiopathic Chilblains (Baseline)

ACTIVE COMPARATOR

Throughout the experiment, the participants remained seated in a sitting position. The trial began with the chamber's temperature at 22-24°C and 40-50% (relative humidity) for 20 minutes. After 20 minutes, the temperature was maintained at 22°C and 40-50% (relative humidity) for 15 minutes, and an occlusion foot test was conducted (5 minutes ''baseline'' phase, 5 minutes ''occlusion'' phase and 5 minutes ''release'' phase), to observe any hemodynamic changes in the foot.

Behavioral: Assessment of Vasomotion of People With Idiopathic Chilblains

Interventions

Assessment of Vasomotion of People With Idiopathic Chilblains BEHAVIORAL

Investigation of vasomotion of people with and without idiopathic chilblains

Progressive acclimation of healthy individuals with Idiopathic Chilblains; Progressive acclimation of healthy individuals with Idiopathic Chilblains (Rewarming Phase); Progressive acclimation of healthy individuals without Idiopathic Chilblains; Progressive acclimation of healthy individuals without Idiopathic Chilblains (Rewarming Phase); Thermoneutral environment healthy participants with Idiopathic Chilblains (Baseline); Thermoneutral environment healthy participants without Idiopathic Chilblains (Baseline)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals with and without idiopathic chilblains.

You may not qualify if:

• Non-healthy individuals or any underlying connective tissue disorders (particularly: Raynaud syndrome/phenomenon, Systemic Lupus Erythematosus, Scleroderma)

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

FAME Lab, Department of Exercise Science, University of Thessaly Tríkala, Thessaly, Greece, 42100

Trikala, Greece

Location

MeSH Terms

Conditions

Chilblains

Condition Hierarchy (Ancestors)

Frostbite; Cold Injury; Wounds and Injuries

Study Officials

• Andreas Flouris, PhD

  FAME Lab, Department of Exercise Science, University of Thessaly Tríkala, Thessaly, Greece, 42100

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher in human physiology, University of Thessaly

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: February 1, 2024
• Study Start: March 15, 2022
• Primary Completion: April 15, 2022
• Study Completion: August 15, 2022
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

GR (1)