TemperatureECCRIOGASNCT05915234
Effect of Cryotherapy Modalities on Skin Temperature, Radial Artery Size and Flow Where Arterial Puncture Are Performed
A study testing Crushed ice, Frozen peas and Room temperature gel in people with Temperature and Blood Flow Velocity, run by Julio Alberto Mateos Arroyo at 1 site in Spain.
Trial summary
Low-intervention clinical trial. The thermal and hemodynamic effects of different cryotherapy devices are evaluated. This study is included in the doctoral thesis of the principal investigator. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temperature, Blood Flow Velocity, Radial Artery Size
- What is being tested?
- Crushed ice, Frozen peas and Room temperature gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2026to Jun 2028
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health.
- Conscientious, with full cognitive and communicative capacity.
- Signed informed consent for this randomized clinical trial.
Who cannot join
- Active smoker.
- Cardiovascular disease.
- Peripheral vascular disease.
- Cyanosis of hands and fingers, Raynaud's Syndrome, Scleroderma and/or CREST Syndrome.
- Diabetes.
- Surgery, recent wounds or any type of major injury affecting the neck, shoulder girdle, upper limbs and/or hands.
Show all 10Show fewer
- Carrier of an arterio-venous fistula.
- Lack of sensitivity to cold.
- Alcohol or caffeine intake in the last 24 hours.
- Intense physical exercise in the last 24 hours.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Gerencia de Atención Integrada de Talavera de la Reina
Talavera de la Reina, Toledo, 45600
About this study
Official title: Analysis of the Effect of Different Cryotherapy Procedures on the Radial Puncture Site for Blood Gas Analysis Randomized Controlled Trial
Low-intervention clinical trial. The thermal and hemodynamic effects of different cryotherapy devices are evaluated. This study is included in the doctoral thesis of the principal investigator.
Investigators:
Read more
Principal Investigator: Julio Alberto Mateos Arroyo (RN, MSc, PhD student) Directors: Ignacio Zaragoza García (RN, PhD), Ismael Ortuño Soriano (RN, PhD), Paloma Posada Moreno (PhD).
Setting: Faculty of Nursing, Physiotherapy and Podiatry of the Universidad Complutense de Madrid.
The three interventions to be evaluated are:
- Applying crushed ice.
- Apply frozen peas.
- Apply comparator.
Hypothesis: There are differences in the reduction of temperature, dimensions of the internal lumen of the radial artery and blood flow inside it depending on the different modalities of cryotherapy (crushed ice or bag of frozen peas) applied in the anatomical area of the wrist, point of arterial puncture for blood gas analysis.
Main objective: To analyze the effect of 3 cryotherapy devices on the radial artery area.
Secondary objectives
- To analyze the thermal behavior of the superficial tissue under study according to the cryotherapy device used.
- To analyze the differences in the radial artery caliber before and after the application of cold in the different experimental modalities under study.
- To analyze the differences in radial artery blood flow before and after the application of cold in the different experimental modalities under study.
- To identify the safety pattern of the use of the different cryotherapy devices (adverse events).
Design: Randomized controlled clinical trial. This is a crossover clinical trial in which all participants will receive all interventions and will be randomized in the order in which they receive them.
Population: Adults with a good general state of health, who specifically do not have factors that could affect their thermoregulation or vascular pathologies.
Main variables:
- Skin surface temperature.
- Radial artery size.
- Radial artery blood flow.
Read the detailed description
Pain caused by arterial puncture for blood gas analysis is one of the most common problems with this procedure. The low utilization rates of effective methods by healthcare providers for pain reduction, such as subcutaneous infiltration of anesthetics, make it necessary to search for effective and simple methods. The use of cryotherapy devices has proven effective for this purpose because the decrease in temperature increases pain threshold and tolerance due to a reduction in nerve conduction velocity and inhibition of nociceptors. In order to standardize these devices, it is necessary to understand the specific thermodynamic and hemodynamic effects of these devices. At the hemodynamic level, the reduction in temperature can produce arterial vasoconstriction. This effect may decrease the palpation of the radial artery, a necessary step for the identification of the optimal point of arterial puncture. Our hypothesis is that there are differences in temperature reduction, radial artery internal lumen dimensions and blood flow inside the radial artery depending on the different cryotherapy modalities applied in the anatomical area of the wrist, the point of arterial puncture for blood gas analysis. In order to obtain an answer to this hypothesis, we will propose a randomized controlled clinical trial with a sham comparator and two active interventions: crushed ice and frozen peas. In addition, this trial has a crossover design with the aim of minimizing the differences that may arise due to individual particularities (within-group variability), and thus increase the possible effect of the interventions (between-group variability). This choice has its justification in that the application of cryotherapy, according to some studies, has a thermal reducing effect with high individual variability. In this study, adults with a good general state of health, who specifically do not have factors that could affect their thermoregulation or vascular pathologies, will be recruited.
- Conditions
- Temperature, Blood Flow Velocity, Radial Artery Size
- Being tested
- Crushed ice, Frozen peas, Room temperature gel
- Keywords
- Cryotherapy, Skin temperature, Radial artery, Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crushed iceDevice
Also called ih1
Each participant will receive two active devices and one sham comparator in a crossover design.The cryotherapy device used consists of an opaque bag with a plastic outer cover and an aluminum interior filled with 80 grams of crushed ice. This device is applied on the skin where the optimal palpation point of the radial artery is located, where arterial puncture for blood gas analysis is usually performed to reduce skin temperature in ranges that decrease nerve conduction velocity and increase pain threshold.
Frozen peasDevice
Also called ig2
Each participant will receive two active devices and one sham comparator in a crossover design. The cryotherapy device used consists of an opaque bag with a plastic outer cover and an aluminum interior filled with 80 grams of frozen peas. This device is applied on the skin where the optimal palpation point of the radial artery is located, where arterial puncture for blood gas analysis is usually performed to reduce skin temperature in ranges that decrease nerve conduction velocity and increase pain threshold.
Room temperature gelDevice
Also called ctrl
Each participant will receive two active devices and one sham comparator in a crossover design. The sham comparator device used consists of an opaque bag with an external plastic cover and an aluminum interior filled with 80 grams of ultrasound gel at room temperature. This device is applied on the skin where the optimal palpation point of the radial artery is located, where arterial puncture for blood gas analysis is usually performed.
| Study group | Role | What they receive |
|---|---|---|
| Order number 1: Ice-Peas-Control | Experimental | Each subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: crushed ice - frozen peas - control. Receives: Device: Crushed ice; Device: Frozen peas; Device: Room temperature gel |
| Order number 2: Ice-Control-Peas | Experimental | Each subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: crushed ice - control - frozen peas. Receives: Device: Crushed ice; Device: Frozen peas; Device: Room temperature gel |
| Order number 3: Peas-Ice-Control | Experimental | Each subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: frozen peas - crushed ice - control. Receives: Device: Crushed ice; Device: Frozen peas; Device: Room temperature gel |
| Order number 4: Peas-Control-Ice | Experimental | Each subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: frozen peas - control - crushed ice. Receives: Device: Crushed ice; Device: Frozen peas; Device: Room temperature gel |
| Order number 5: Control-Ice-Peas | Experimental | Each subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: control - crushed ice - frozen peas. Receives: Device: Crushed ice; Device: Frozen peas; Device: Room temperature gel |
| Order number 6: Control-Peas-Ice | Experimental | Each subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: control - frozen peas - crushed ice. Receives: Device: Crushed ice; Device: Frozen peas; Device: Room temperature gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin temperature
Surface temperature measurements will be taken at different times since the application of the interventions. The thermal camera FLIR TG267 will be used, temperature range: -25ºC to 380ºC, sensitivity <70ºC mK, resolution 160 X 120.
Measured: Prior to application of the intervention
Skin temperature
Surface temperature measurements will be taken at different times since the application of the interventions. The thermal camera FLIR TG267 will be used, temperature range: -25ºC to 380ºC, sensitivity <70ºC mK, resolution 160 X 120.
Measured: After 5 minutes from the application of the intervention
Skin temperature
Surface temperature measurements will be taken at different times since the application of the interventions. The thermal camera FLIR TG267 will be used, temperature range: -25ºC to 380ºC, sensitivity <70ºC mK, resolution 160 X 120.
Measured: After 10 minutes from the application of the intervention
Skin temperature
Surface temperature measurements will be taken at different times since the application of the interventions. The thermal camera FLIR TG267 will be used, temperature range: -25ºC to 380ºC, sensitivity <70ºC mK, resolution 160 X 120.
Measured: After 15 minutes from the application of the intervention
Skin temperature
Surface temperature measurements will be taken at different times since the application of the interventions. The thermal camera FLIR TG267 will be used, temperature range: -25ºC to 380ºC, sensitivity <70ºC mK, resolution 160 X 120.
Measured: After 20 minutes from the application of the intervention
Secondary outcomes (2)
Change in radial artery size
Three measurements of the anteroposterior diameter of the radial artery will be taken in the same place and plane to ensure reliability at each time point studied. Samsung HS50 ultrasound scanner with a 3-14 Hz linear probe will be used for the measurement.
Measured: 0-20 minutes
Change in radial artery blood flow
To obtain the blood flow of the radial artery, color Doppler mode will be used to correctly identify the vessel and then the pulsed Doppler mode will be used to obtain the peak systolic low (PSV), that is, the maximum systolic velocity (VSM). Three consecutive PSV measurements will be obtained in the same place and plane to ensure reliability at each time point studied. Samsung HS50 ultrasound scanner with a 3-14 Hz linear probe will be used for the measurement.
Measured: 0-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Why it stopped: The study has been postponed indefinitely. It is likely to be carried out in 2026-27
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TemperatureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized experimental model in which 2 active cryotherapy interventions and a control are applied to all participants in a crossover single-blind design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julio Alberto Mateos Arroyo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Complutense de Madrid, Hospital General Nuestra Señora del Prado
- Responsible party
- Sponsor-investigator, Julio Alberto Mateos Arroyo, Hospital General Nuestra Señora del Prado
- Investigators
- Ignacio Zaragoza García, RN, PhD, Study director, Universidad Complutense de MadridIsmael Ortuño Soriano, RN, PhD, Study director, Universidad Complutense de MadridPaloma Posada Moreno, PhD, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915234
- Sponsor's protocol ID
- ECCRIOGAS
- Acronym
- ECCRIOGAS
- Status last verified
- Aug 2025
- First submitted
- 4 Jun 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effect of Different Cryotherapy Procedures on the Radial Puncture Site for Blood Gas Analysis Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05915234
- Acronym / sponsor ID
- ECCRIOGAS / ECCRIOGAS
- Conditions
- Temperature, Blood Flow Velocity, Radial Artery Size
- Keywords
- Cryotherapy, Skin temperature, Radial artery, Hemodynamics
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study has been postponed indefinitely. It is likely to be carried out in 2026-27
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Julio Alberto Mateos ArroyoUniversity, hospital or other
- Collaborators
- Universidad Complutense de Madrid, Hospital General Nuestra Señora del Prado
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Jun 2023 (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.
Low-intervention clinical trial. The thermal and hemodynamic effects of different cryotherapy devices are evaluated. This study is included in the doctoral thesis of the principal investigator.
Investigators:
Principal Investigator: Julio Alberto Mateos Arroyo (RN, MSc, PhD student) Directors: Ignacio Zaragoza García (RN, PhD), Ismael Ortuño Soriano (RN, PhD), Paloma Posada Moreno (PhD).
Setting: Faculty of Nursing, Physiotherapy and Podiatry of the Universidad Complutense de Madrid.
The three interventions to be evaluated are:
- Applying crushed ice.
- Apply frozen peas.
- Apply comparator.
Hypothesis: There are differences in the reduction of temperature, dimensions of the internal lumen of the radial artery and blood flow inside it depending on the different modalities of cryotherapy (crushed ice or bag of frozen peas) applied in the anatomical area of the wrist, point of arterial puncture for blood gas analysis.
Main objective: To analyze the effect of 3 cryotherapy devices on the radial artery area.
Secondary objectives
- To analyze the thermal behavior of the superficial tissue under study according to the cryotherapy device used.
- To analyze the differences in the radial artery caliber before and after the application of cold in the different experimental modalities under study.
- To analyze the differences in radial artery blood flow before and after the application of cold in the different experimental modalities under study.
- To identify the safety pattern of the use of the different cryotherapy devices (adverse events).
Design: Randomized controlled clinical trial. This is a crossover clinical trial in which all participants will receive all interventions and will be randomized in the order in which they receive them.
Population: Adults with a good general state of health, who specifically do not have factors that could affect their thermoregulation or vascular pathologies.
Main variables:
- Skin surface temperature.
- Radial artery size.
- Radial artery blood flow.
Detailed description
Pain caused by arterial puncture for blood gas analysis is one of the most common problems with this procedure. The low utilization rates of effective methods by healthcare providers for pain reduction, such as subcutaneous infiltration of anesthetics, make it necessary to search for effective and simple methods. The use of cryotherapy devices has proven effective for this purpose because the decrease in temperature increases pain threshold and tolerance due to a reduction in nerve conduction velocity and inhibition of nociceptors. In order to standardize these devices, it is necessary to understand the specific thermodynamic and hemodynamic effects of these devices. At the hemodynamic level, the reduction in temperature can produce arterial vasoconstriction. This effect may decrease the palpation of the radial artery, a necessary step for the identification of the optimal point of arterial puncture. Our hypothesis is that there are differences in temperature reduction, radial artery internal lumen dimensions and blood flow inside the radial artery depending on the different cryotherapy modalities applied in the anatomical area of the wrist, the point of arterial puncture for blood gas analysis. In order to obtain an answer to this hypothesis, we will propose a randomized controlled clinical trial with a sham comparator and two active interventions: crushed ice and frozen peas. In addition, this trial has a crossover design with the aim of minimizing the differences that may arise due to individual particularities (within-group variability), and thus increase the possible effect of the interventions (between-group variability). This choice has its justification in that the application of cryotherapy, according to some studies, has a thermal reducing effect with high individual variability. In this study, adults with a good general state of health, who specifically do not have factors that could affect their thermoregulation or vascular pathologies, will be recruited.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Randomized experimental model in which 2 active cryotherapy interventions and a control are applied to all participants in a crossover single-blind design.
| Arm | Type | Receives |
|---|---|---|
| Order number 1: Ice-Peas-Control | Experimental | Device: Crushed ice, Device: Frozen peas, Device: Room temperature gelEach subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: crushed ice - frozen peas - control. |
| Order number 2: Ice-Control-Peas | Experimental | Device: Crushed ice, Device: Frozen peas, Device: Room temperature gelEach subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: crushed ice - control - frozen peas. |
| Order number 3: Peas-Ice-Control | Experimental | Device: Crushed ice, Device: Frozen peas, Device: Room temperature gelEach subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: frozen peas - crushed ice - control. |
| Order number 4: Peas-Control-Ice | Experimental | Device: Crushed ice, Device: Frozen peas, Device: Room temperature gelEach subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: frozen peas - control - crushed ice. |
| Order number 5: Control-Ice-Peas | Experimental | Device: Crushed ice, Device: Frozen peas, Device: Room temperature gelEach subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: control - crushed ice - frozen peas. |
| Order number 6: Control-Peas-Ice | Experimental | Device: Crushed ice, Device: Frozen peas, Device: Room temperature gelEach subject will receive all interventions and the control and they will randomly assigned to a sequence order. In this arm the sequence order is: control - frozen peas - crushed ice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Good general health.
- Conscientious, with full cognitive and communicative capacity.
- Signed informed consent for this randomized clinical trial.
Key exclusion criteria (10 listed)
- Active smoker.
- Cardiovascular disease.
- Peripheral vascular disease.
- Cyanosis of hands and fingers, Raynaud's Syndrome, Scleroderma and/or CREST Syndrome.
- Diabetes.
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 |
|---|---|---|
| Crushed iceAlso: ih1Each participant will receive two active devices and one sham comparator in a crossover design.The cryotherapy device used consists of an opaque bag with a plastic outer cover and an aluminum interior filled with 80 grams of crushed ice. This device is applied on the skin where the optimal palpation point of the radial artery is located, where arterial puncture for blood gas analysis is usually performed to reduce skin temperature in ranges that decrease nerve conduction velocity and increase pain threshold. | Device | Order number 1: Ice-Peas-Control, Order number 2: Ice-Control-Peas, Order number 3: Peas-Ice-Control, Order number 4: Peas-Control-Ice, Order number 5: Control-Ice-Peas, Order number 6: Control-Peas-Ice |
| Frozen peasAlso: ig2Each participant will receive two active devices and one sham comparator in a crossover design. The cryotherapy device used consists of an opaque bag with a plastic outer cover and an aluminum interior filled with 80 grams of frozen peas. This device is applied on the skin where the optimal palpation point of the radial artery is located, where arterial puncture for blood gas analysis is usually performed to reduce skin temperature in ranges that decrease nerve conduction velocity and increase pain threshold. | Device | Order number 1: Ice-Peas-Control, Order number 2: Ice-Control-Peas, Order number 3: Peas-Ice-Control, Order number 4: Peas-Control-Ice, Order number 5: Control-Ice-Peas, Order number 6: Control-Peas-Ice |
| Room temperature gelAlso: ctrlEach participant will receive two active devices and one sham comparator in a crossover design. The sham comparator device used consists of an opaque bag with an external plastic cover and an aluminum interior filled with 80 grams of ultrasound gel at room temperature. This device is applied on the skin where the optimal palpation point of the radial artery is located, where arterial puncture for blood gas analysis is usually performed. | Device | Order number 1: Ice-Peas-Control, Order number 2: Ice-Control-Peas, Order number 3: Peas-Ice-Control, Order number 4: Peas-Control-Ice, Order number 5: Control-Ice-Peas, Order number 6: Control-Peas-Ice |
Primary outcome
Skin temperature
Time frame: Prior to application of the intervention
Surface temperature measurements will be taken at different times since the application of the interventions. The thermal camera FLIR TG267 will be used, temperature range: -25ºC to 380ºC, sensitivity <70ºC mK, resolution 160 X 120.
Skin temperature
Time frame: After 5 minutes from the application of the intervention
Surface temperature measurements will be taken at different times since the application of the interventions. The thermal camera FLIR TG267 will be used, temperature range: -25ºC to 380ºC, sensitivity <70ºC mK, resolution 160 X 120.
Skin temperature
Time frame: After 10 minutes from the application of the intervention
Surface temperature measurements will be taken at different times since the application of the interventions. The thermal camera FLIR TG267 will be used, temperature range: -25ºC to 380ºC, sensitivity <70ºC mK, resolution 160 X 120.
Skin temperature
Time frame: After 15 minutes from the application of the intervention
Surface temperature measurements will be taken at different times since the application of the interventions. The thermal camera FLIR TG267 will be used, temperature range: -25ºC to 380ºC, sensitivity <70ºC mK, resolution 160 X 120.
Skin temperature
Time frame: After 20 minutes from the application of the intervention
Surface temperature measurements will be taken at different times since the application of the interventions. The thermal camera FLIR TG267 will be used, temperature range: -25ºC to 380ºC, sensitivity <70ºC mK, resolution 160 X 120.
2 secondary outcomes
Change in radial artery size
Time frame: 0-20 minutes
Change in radial artery blood flow
Time frame: 0-20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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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.
Ignacio Zaragoza García, RN, PhD study director
Universidad Complutense de Madrid
Ismael Ortuño Soriano, RN, PhD study director
Universidad Complutense de Madrid
Paloma Posada Moreno, PhD study director
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crushed ice, Frozen peas and Room temperature gel in people with Temperature and Blood Flow Velocity, run by Julio Alberto Mateos Arroyo at 1 site in Spain.
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 3 inclusion and 10 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: paused, as of the sponsor's last update on 22 Aug 2025. 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 Spain. 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?
Results are not available in the source record.
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?
Skin temperature (time frame: Prior to application of the intervention). The study lists 5 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 22 Aug 2025.