ChilblainsNCT06237517
Assessment of Vasomotion of People With Idiopathic Chilblains
A study testing Assessment of Vasomotion of People With Idiopathic Chilblains in people with Chilblains and Perniosis, run by University of Thessaly at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chilblains, Perniosis, Thermoregulation
- What is being tested?
- Assessment of Vasomotion of People With Idiopathic Chilblains
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGreece
- Study dates
- 15 Mar 2022to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals with and without idiopathic chilblains.
Who cannot join
- Non-healthy individuals or any underlying connective tissue disorders (particularly: Raynaud syndrome/phenomenon, Systemic Lupus Erythematosus, Scleroderma)
Trial locations and contacts
1 site in 1 country.
Greece1 site
FAME Lab, Department of Exercise Science, University of Thessaly Tríkala, Thessaly, Greece, 42100
Trikala
About this study
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).
Read the 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:
- Thermoneutral environment 22-24°C and 40-50% relative humidity for 15 minutes.
- Thermoneutral environment of 22-24°C and 40-50% relative humidity, the temperature within the chamber was decreased by 4 degrees every 20 minutes.
- 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
- Being tested
- Assessment of Vasomotion of People With Idiopathic Chilblains
- Keywords
- Non-freezing cold injuries, Chilblains, Perniosis, Skin lesions, Vasomotion
- Medical subject headings
- Chilblains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Vasomotion of People With Idiopathic ChilblainsBehavioural
Investigation of vasomotion of people with and without idiopathic chilblains
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Assessment of Vasomotion of People With Idiopathic Chilblains |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start15 Mar 2022
- Primary completion15 Apr 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChilblainsStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petros Dinas, University of Thessaly
- Investigators
- Andreas Flouris, PhD, Principal investigator, FAME Lab, Department of Exercise Science, University of Thessaly Tríkala, Thessaly, Greece, 42100
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237517
- Sponsor's protocol ID
- 1888
- Status last verified
- Mar 2024
- First submitted
- 21 Jan 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vasomotion of People With Idiopathic Chilblains
- ClinicalTrials.gov ID
- NCT06237517
- Acronym / sponsor ID
- 1888
- Conditions
- Chilblains, Perniosis, Thermoregulation
- Keywords
- Non-freezing cold injuries, Chilblains, Perniosis, Skin lesions, Vasomotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Thermoneutral environment 22-24°C and 40-50% relative humidity for 15 minutes.
- Thermoneutral environment of 22-24°C and 40-50% relative humidity, the temperature within the chamber was decreased by 4 degrees every 20 minutes.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Progressive acclimation of healthy individuals with Idiopathic Chilblains | Experimental | Behavioral: Assessment of Vasomotion of People With Idiopathic ChilblainsThroughout 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. |
| Progressive acclimation of healthy individuals with Idiopathic Chilblains (Rewarming Phase) | Experimental | Behavioral: Assessment of Vasomotion of People With Idiopathic ChilblainsThroughout 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. |
| Progressive acclimation of healthy individuals without Idiopathic Chilblains | Active comparator | Behavioral: Assessment of Vasomotion of People With Idiopathic ChilblainsThroughout 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. |
| Progressive acclimation of healthy individuals without Idiopathic Chilblains (Rewarming Phase) | Active comparator | Behavioral: Assessment of Vasomotion of People With Idiopathic ChilblainsThroughout 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. |
| Thermoneutral environment healthy participants with Idiopathic Chilblains (Baseline) | Experimental | Behavioral: Assessment of Vasomotion of People With Idiopathic ChilblainsThroughout 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. |
| Thermoneutral environment healthy participants without Idiopathic Chilblains (Baseline) | Active comparator | Behavioral: Assessment of Vasomotion of People With Idiopathic ChilblainsThroughout 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals with and without idiopathic chilblains.
Key exclusion criteria (1 listed)
- Non-healthy individuals or any underlying connective tissue disorders (particularly: Raynaud syndrome/phenomenon, Systemic Lupus Erythematosus, Scleroderma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of Vasomotion of People With Idiopathic ChilblainsInvestigation of vasomotion of people with and without idiopathic chilblains | Behavioural | 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) |
Primary outcome
Heart rate
Time frame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
Heart rate were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Heart rate variability
Time frame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
Heart rate variability were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Skin blood flow
Time frame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
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.
Skin temperature
Time frame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
Skin temperature (forehead, arm, thigh, hand, foot, tibialis anterior, navel) was continuously monitored using iButton sensors type DS1921 H, Maxim/Dallas Semiconductor Corp., USA.
Finger temperature
Time frame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
Finger temperature were monitored throughout the trial using a data logger interfacing with a computer to allow for their continuous monitoring by the investigators.
Hemoglobin oxygen saturation in a localized tissue (foot)
Time frame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
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).
Body core temperature
Time frame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
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.
Thermal comfort
Time frame: 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 comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).
Thermal sensation
Time frame: 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)
Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)
Blood samples
Time frame: 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.
Participants were provided blood samples (C-reactive protein and Cortisol).
Urine sample
Time frame: 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.
Participants were provided urine samples (urine specific gravity)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
Related trials for Chilblains
RecruitingObservational study
Assessment of Chilbains Occuring During Covid-19 Infection
Skin Manifestations, COVID
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Flouris, PhD principal investigator
FAME Lab, Department of Exercise Science, University of Thessaly Tríkala, Thessaly, Greece, 42100
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of Vasomotion of People With Idiopathic Chilblains in people with Chilblains and Perniosis, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.