Clinical trial NCT06237517: Assessment of Vasomotion of People With Idiopathic Chilblains
Official title: Assessment of Vasomotion of People With Idiopathic Chilblains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chilblains
Perniosis
Thermoregulation
Keywords: Non-freezing cold injuries
Chilblains
Perniosis
Skin lesions
Vasomotion
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Heart rate
timeFrame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
measure: Heart rate variability
timeFrame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
measure: Skin blood flow
timeFrame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
measure: Skin temperature
timeFrame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
measure: Finger temperature
timeFrame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
measure: Hemoglobin oxygen saturation in a localized tissue (foot)
timeFrame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
measure: Body core temperature
timeFrame: 1 hour and 35 minutes (trial without rewarming), 1 hour and 55 minutes (trial with rewarming)
measure: Thermal comfort
timeFrame: 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)
measure: Thermal sensation
timeFrame: 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)
measure: Blood samples
timeFrame: 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.
measure: Urine sample
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Trikala
country: Greece
facility: FAME Lab, Department of Exercise Science, University of Thessaly Tríkala, Thessaly, Greece, 42100
Study officials:
affiliation: FAME Lab, Department of Exercise Science, University of Thessaly Tríkala, Thessaly, Greece, 42100
name: Andreas Flouris, PhD
role: PRINCIPAL_INVESTIGATOR
References: