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NCT Number: NCT06237517

Assessment of Vasomotion of People With Idiopathic Chilblains

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).

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Key information

Conditions

Chilblains Cold Injury Frostbite Perniosis Thermoregulation Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Trikala, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Assessment of Vasomotion of People With Idiopathic Chilblains

Behavioral

Investigation of vasomotion of people with and without idiopathic chilblains

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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).

  9. 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)

  10. 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).

  11. 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)

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2024
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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