Assessment of Vasomotion of People With Idiopathic Chilblains

NCT ID: NCT06237517

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2022-08-15

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).

Detailed 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.

Conditions

Chilblains; Perniosis; Thermoregulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Progressive acclimation of healthy individuals with Idiopathic Chilblains

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.

Group Type: EXPERIMENTAL

Assessment of Vasomotion of People With Idiopathic Chilblains

Intervention Type: BEHAVIORAL

Investigation of vasomotion of people with and without idiopathic chilblains

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

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.

Group Type: EXPERIMENTAL

Assessment of Vasomotion of People With Idiopathic Chilblains

Intervention Type: BEHAVIORAL

Investigation of vasomotion of people with and without idiopathic chilblains

Progressive acclimation of healthy individuals without Idiopathic Chilblains

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.

Group Type: ACTIVE_COMPARATOR

Assessment of Vasomotion of People With Idiopathic Chilblains

Intervention Type: BEHAVIORAL

Investigation of vasomotion of people with and without idiopathic chilblains

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

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.

Group Type: ACTIVE_COMPARATOR

Assessment of Vasomotion of People With Idiopathic Chilblains

Intervention Type: BEHAVIORAL

Investigation of vasomotion of people with and without idiopathic chilblains

Thermoneutral environment healthy participants with Idiopathic Chilblains (Baseline)

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.

Group Type: EXPERIMENTAL

Assessment of Vasomotion of People With Idiopathic Chilblains

Intervention Type: BEHAVIORAL

Investigation of vasomotion of people with and without idiopathic chilblains

Thermoneutral environment healthy participants without Idiopathic Chilblains (Baseline)

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.

Group Type: ACTIVE_COMPARATOR

Assessment of Vasomotion of People With Idiopathic Chilblains

Intervention Type: BEHAVIORAL

Investigation of vasomotion of people with and without idiopathic chilblains

Interventions

Assessment of Vasomotion of People With Idiopathic Chilblains

Investigation of vasomotion of people with and without idiopathic chilblains

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Thessaly

OTHER

Sponsor Role: lead

Responsible Party

Petros Dinas

Senior Researcher in human physiology, University of Thessaly

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Flouris, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Trikala, , Greece

Countries

Greece

Other Identifiers

1888

Identifier Type: -

Identifier Source: org_study_id