Temperature Change, BodyNCT05136482
Skin Temperature Changes When Using a Cryocompression Device
A study testing Cryocompression in people with Temperature Change, Body, run by University of Winchester at 1 site in United Kingdom.
Trial summary
Cryotherapy after surgery is widely utilised and has numerous practical applications for post-operative rehabilitation. Previous research has suggested that during cold therapy, the skin temperature of the knee should be reduced to 10-15°C to maximise the therapeutic benefits of cooling while avoiding the risk of cold… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temperature Change, Body
- What is being tested?
- Cryocompression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Nov 2021to 11 May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years of age.
Who cannot join
- BMI >40 kg/m2
- History of nerve damage or sensory deficit in the lower limbs (including frostbite)
- Hypersensitivity to cold, including hives
- Active inflammation or pain of the knee
- History of thrombosis, embolism, or other conditions related to impaired peripheral circulation
- Suffering from diagnosed diabetes, multiple sclerosis, rheumatoid arthritis, spinal cord injury, cardio-vascular disease, hypertension, Raynaud disease, cryoglobulinemia, or haemoglobinuria
Show all 9Show fewer
- Confirmed or suspected tissue infection, an unstable fracture, a skin condition, or a tumour in the treatment area
- Cognitive impairment or communication barriers
- These criteria have been selected in accordance with the common contraindications for cold therapy (Selfe et al, 2009; Fang et al, 2012; Waterman et al, 2012) and those laid out in the manufacturer's guidelines of the specific device to be used (S1; Physiolab Technologies Ltd)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Continuous Cold-flow Cryocompression Device to Reduce the Skin Temperature of the Knee to the Therapeutic Range of 10-15℃: a Randomised Controlled Trial
Cryotherapy after surgery is widely utilised and has numerous practical applications for post-operative rehabilitation. Previous research has suggested that during cold therapy, the skin temperature of the knee should be reduced to 10-15°C to maximise the therapeutic benefits of cooling while avoiding the risk of cold injuries such as nerve damage and frostbite (Wilke and Weiner, 2003; Bleakley, McDonough and MacAuley, 2004). The temperature range at which a device cryocompression device should be set in order to achieve a skin temperature within the therapeutic range of 10-15°C is unknown. Furthermore, there is evidence to suggest that the temperature of the device does not equal that to which the skin is reduced, plus different devices do not achieve the same reduction in skin temperature despite the ice-water within the knee sleeve being maintained at similar temperatures (Selfe et al., 2009). Therefore, it is not sufficient to assume that the temperature setting of a cryo-compression device reflects the skin temperature achieved.
The aim of this study is to determine which temperature of ice-water flowing through a Physiolab S1 cryocompression device is able to reduce skin temperature around the knee to within the previously stated therapeutic range.
Read the detailed description
Design This prospective randomised controlled trial will recruit healthy adult volunteers from a university population to participate. Each participant will take part in each condition within the study in order to eliminate the risk of demographic factors confounding the results: Conditions will be conducted in a random order and will be named: control, A, B, C, and D. The control condition will involve the cryocompression device being worn without any ice-water being circulated through the knee sleeve. Conditions A, B, C, and D will involve the device being worn while ice-water is circulated through the knee sleeve at a maintained temperature of 6°C, 8°C, 10°C, or 12°C, respectively. Randomisation will be performed using a computer random number generator.
Protocol All eligible participants will first be required to provide informed consent prior to their participation in the study. Once this has been obtained, participants will each attend a single testing session that should last no longer than 60 minutes. The height and mass of the participants will first be measured in order to calculate BMI, and participants' age and sex will be recorded to allow for later analysis to determine any confounding influence of these factors on the results.
Participants will be required to remain in a seated position with their leg in full extension and elevated, parallel to the floor, for the duration of each test session. The leg that will be used for the study will be randomly selected for each participant, and will remain the same for each condition. A k-type thermocouple will be taped 20 mm distal to the patella and the Physiolab S1 cryocompression device will then be attached to the leg of the participant. Depending on the condition to which a participant has been assigned for a given test, the S1 will maintain the temperature of the water flowing through the device at either 6, 8, 10, or 12℃. The control condition will involve the device being applied to the leg with no ice/water flowing through the cuff. The cuff will be worn for 30 minutes as per the manufacturers guidelines for cold therapy treatments. After 30 minutes, the cuff will be removed. If the temperature of the skin has been reduced to within 10-15℃, skin temperature will continue to be monitored every 5 minutes after the cuff has been removed until it rises above 15℃, at which point the test will end. If the skin temperature is not reduced to within 10-15℃ while the cuff is worn, then the test will end after the cuff is removed at 30 minutes. Upon completion of the test, the temperature sensor will be removed from the leg of the participant; thus completing their participation in the test.
Analysis The data will be analysed to detect any differences during testing compared to baseline measures, and between groups. All data will be first subjected to a Kolmogorov-Smirnov test to assess whether they are normally distributed. A repeated measures analysis of variance will be performed on all normally distributed data. A Friedman test will be performed on any data that are not normally distributed.
Ethical issues There is a low risk of cold injury to participants if their skin temperature reduces to <10℃. Skin temperature will be monitored every 5 minutes throughout the study and testing will be terminated if a participant's skin temperature dips below this threshold. Therefore, the risk to participants in this study is minimal.
Participants have the right to withdraw themselves and any collected data from the study at any time during and after their participation, without having to give a reason. They also have the right to terminate a test session at any time. Testing shall also be terminated as a result of any adverse reactions that emerge. Adverse reactions (e.g. pain) to the testing protocol are not expected due to the low-risk nature of the study, however any that occur shall be recorded and monitored until things return to baseline/normal. In order to monitor any pain/discomfort that might occur, a Visual Analogue Scale (0-10 scale) will be within sight of the participant at all times during testing: a test will be terminated if reported pain/discomfort exceeds 5/10, though none is expected. Any reported pain (or other adverse reactions) shall be stored along with the data collected for that participant. If a test is terminated for a reason that could be mitigated in future, participants will be offered the opportunity to repeat the test another day, should they wish to continue taking part in the study. If a test is terminated due to an adverse reaction that can not be mitigated in future, the participant (and any collected data) will be thanked for their time and withdrawn from the study.
- Conditions
- Temperature Change, Body
- Being tested
- Cryocompression
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryocompressionDevice
A cryocompression device will be attached to the lower limb of participants using a cuff spanning from the mid-thigh to mid-calf. The device will exert a constant pressure of 25 mmHg throughout each test session. The device will pump temperature-controlled cold water through the cuff in order to reduce the skin temperature around the knee (and intra-articular temperature). Depending on the condition, the temperature of the water being pumped through the device will be either 6, 8, 10, or 12℃. Each test session will last for 30 minutes. Participants will take part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee will be measured prior to the cryocompression device being applied; every 5 minutes during the 30 minute test; and every 5 minutes after the test until skin temperature >15℃.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will wear the cryocompression device for 30 mins without any cold or pressure being applied to the lower limb by the cuff. |
| Condition A | Experimental | Participants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 6℃ and a pressure of 25 mmHg is applied to the lower limb by the cuff. Receives: Device: Cryocompression |
| Condition B | Experimental | Participants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 8℃ and a pressure of 25 mmHg is applied to the lower limb by the cuff. Receives: Device: Cryocompression |
| Condition C | Experimental | Participants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 10℃ and a pressure of 25 mmHg is applied to the lower limb by the cuff. Receives: Device: Cryocompression |
| Condition D | Experimental | Participants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 12℃ and a pressure of 25 mmHg is applied to the lower limb by the cuff. Receives: Device: Cryocompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Temperature
Skin temperature will be measured using a thermocouple positioned 20 mm distal to the patella. This sensor will be attached prior to the cryocompression device being applied, and will remain in place until the testing session is complete and skin temperature is >15℃. (The therapeutic skin temperature range for cryotherapy is thought to be 10-15℃). Temperature will be measured prior to the cryocompression device being applied; every 5 minutes during the test; and every 5 minutes after a test until the skin temperature reaches >15℃.
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start10 Nov 2021
- Primary completion11 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Temperature Change, BodyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Winchester
- Sponsor type
- University, hospital or other
- Collaborators
- Physiolab Technologies Ltd
- Responsible party
- Sponsor
- Investigators
- James Faulkner, PhD, Principal investigator, University of Winchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136482
- Sponsor's protocol ID
- HWB_REC_210927_Faulkner
- Status last verified
- May 2022
- First submitted
- 4 Nov 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data will be shared outside of the researchers directly involved in the data collection itself.
Publications
Wilke B, Weiner RD. Postoperative cryotherapy: risks versus benefits of continuous-flow cryotherapy units. Clin Podiatr Med Surg. 2003 Apr;20(2):307-22. doi: 10.1016/S0891-8422(03)00009-0.
PubMed 12776983Bleakley C, McDonough S, MacAuley D. The use of ice in the treatment of acute soft-tissue injury: a systematic review of randomized controlled trials. Am J Sports Med. 2004 Jan-Feb;32(1):251-61. doi: 10.1177/0363546503260757.
PubMed 14754753Selfe J, Hardaker N, Whittaker J and Hayes C. An investigation into the effect on skin surface temperature of three cryotherapy modalities. Thermology International. 2009; 19(4): 121-126.
Fang L, Hung CH, Wu SL, Fang SH, Stocker J. The effects of cryotherapy in relieving postarthroscopy pain. J Clin Nurs. 2012 Mar;21(5-6):636-43. doi: 10.1111/j.1365-2702.2010.03531.x. Epub 2011 Feb 20.
PubMed 21332855Waterman B, Walker JJ, Swaims C, Shortt M, Todd MS, Machen SM, Owens BD. The efficacy of combined cryotherapy and compression compared with cryotherapy alone following anterior cruciate ligament reconstruction. J Knee Surg. 2012 May;25(2):155-60. doi: 10.1055/s-0031-1299650.
PubMed 22928433
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Continuous Cold-flow Cryocompression Device to Reduce the Skin Temperature of the Knee to the Therapeutic Range of 10-15℃: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05136482
- Acronym / sponsor ID
- HWB_REC_210927_Faulkner
- Conditions
- Temperature Change, Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of WinchesterUniversity, hospital or other
- Collaborators
- Physiolab Technologies Ltd
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 29 Nov 2021 (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.
Cryotherapy after surgery is widely utilised and has numerous practical applications for post-operative rehabilitation. Previous research has suggested that during cold therapy, the skin temperature of the knee should be reduced to 10-15°C to maximise the therapeutic benefits of cooling while avoiding the risk of cold injuries such as nerve damage and frostbite (Wilke and Weiner, 2003; Bleakley, McDonough and MacAuley, 2004). The temperature range at which a device cryocompression device should be set in order to achieve a skin temperature within the therapeutic range of 10-15°C is unknown. Furthermore, there is evidence to suggest that the temperature of the device does not equal that to which the skin is reduced, plus different devices do not achieve the same reduction in skin temperature despite the ice-water within the knee sleeve being maintained at similar temperatures (Selfe et al., 2009). Therefore, it is not sufficient to assume that the temperature setting of a cryo-compression device reflects the skin temperature achieved.
The aim of this study is to determine which temperature of ice-water flowing through a Physiolab S1 cryocompression device is able to reduce skin temperature around the knee to within the previously stated therapeutic range.
Detailed description
Design This prospective randomised controlled trial will recruit healthy adult volunteers from a university population to participate. Each participant will take part in each condition within the study in order to eliminate the risk of demographic factors confounding the results: Conditions will be conducted in a random order and will be named: control, A, B, C, and D. The control condition will involve the cryocompression device being worn without any ice-water being circulated through the knee sleeve. Conditions A, B, C, and D will involve the device being worn while ice-water is circulated through the knee sleeve at a maintained temperature of 6°C, 8°C, 10°C, or 12°C, respectively. Randomisation will be performed using a computer random number generator.
Protocol All eligible participants will first be required to provide informed consent prior to their participation in the study. Once this has been obtained, participants will each attend a single testing session that should last no longer than 60 minutes. The height and mass of the participants will first be measured in order to calculate BMI, and participants' age and sex will be recorded to allow for later analysis to determine any confounding influence of these factors on the results.
Participants will be required to remain in a seated position with their leg in full extension and elevated, parallel to the floor, for the duration of each test session. The leg that will be used for the study will be randomly selected for each participant, and will remain the same for each condition. A k-type thermocouple will be taped 20 mm distal to the patella and the Physiolab S1 cryocompression device will then be attached to the leg of the participant. Depending on the condition to which a participant has been assigned for a given test, the S1 will maintain the temperature of the water flowing through the device at either 6, 8, 10, or 12℃. The control condition will involve the device being applied to the leg with no ice/water flowing through the cuff. The cuff will be worn for 30 minutes as per the manufacturers guidelines for cold therapy treatments. After 30 minutes, the cuff will be removed. If the temperature of the skin has been reduced to within 10-15℃, skin temperature will continue to be monitored every 5 minutes after the cuff has been removed until it rises above 15℃, at which point the test will end. If the skin temperature is not reduced to within 10-15℃ while the cuff is worn, then the test will end after the cuff is removed at 30 minutes. Upon completion of the test, the temperature sensor will be removed from the leg of the participant; thus completing their participation in the test.
Analysis The data will be analysed to detect any differences during testing compared to baseline measures, and between groups. All data will be first subjected to a Kolmogorov-Smirnov test to assess whether they are normally distributed. A repeated measures analysis of variance will be performed on all normally distributed data. A Friedman test will be performed on any data that are not normally distributed.
Ethical issues There is a low risk of cold injury to participants if their skin temperature reduces to <10℃. Skin temperature will be monitored every 5 minutes throughout the study and testing will be terminated if a participant's skin temperature dips below this threshold. Therefore, the risk to participants in this study is minimal.
Participants have the right to withdraw themselves and any collected data from the study at any time during and after their participation, without having to give a reason. They also have the right to terminate a test session at any time. Testing shall also be terminated as a result of any adverse reactions that emerge. Adverse reactions (e.g. pain) to the testing protocol are not expected due to the low-risk nature of the study, however any that occur shall be recorded and monitored until things return to baseline/normal. In order to monitor any pain/discomfort that might occur, a Visual Analogue Scale (0-10 scale) will be within sight of the participant at all times during testing: a test will be terminated if reported pain/discomfort exceeds 5/10, though none is expected. Any reported pain (or other adverse reactions) shall be stored along with the data collected for that participant. If a test is terminated for a reason that could be mitigated in future, participants will be offered the opportunity to repeat the test another day, should they wish to continue taking part in the study. If a test is terminated due to an adverse reaction that can not be mitigated in future, the participant (and any collected data) will be thanked for their time and withdrawn from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will wear the cryocompression device for 30 mins without any cold or pressure being applied to the lower limb by the cuff. |
| Condition A | Experimental | Device: CryocompressionParticipants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 6℃ and a pressure of 25 mmHg is applied to the lower limb by the cuff. |
| Condition B | Experimental | Device: CryocompressionParticipants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 8℃ and a pressure of 25 mmHg is applied to the lower limb by the cuff. |
| Condition C | Experimental | Device: CryocompressionParticipants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 10℃ and a pressure of 25 mmHg is applied to the lower limb by the cuff. |
| Condition D | Experimental | Device: CryocompressionParticipants will wear the cryocompression device for 30 minutes while ice-water at a temperature of 12℃ and a pressure of 25 mmHg is applied to the lower limb by the cuff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 years of age.
Key exclusion criteria (9 listed)
- BMI >40 kg/m2
- These criteria have been selected in accordance with the common contraindications for cold therapy (Selfe et al, 2009; Fang et al, 2012; Waterman et al, 2012) and those laid out in the manufacturer's guidelines of the specific device to be used (S1; Physiolab Technologies Ltd)
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 |
|---|---|---|
| CryocompressionA cryocompression device will be attached to the lower limb of participants using a cuff spanning from the mid-thigh to mid-calf. The device will exert a constant pressure of 25 mmHg throughout each test session. The device will pump temperature-controlled cold water through the cuff in order to reduce the skin temperature around the knee (and intra-articular temperature). Depending on the condition, the temperature of the water being pumped through the device will be either 6, 8, 10, or 12℃. Each test session will last for 30 minutes. Participants will take part in all conditions, with at least 24 hours rest in between test sessions. Skin temperature around the knee will be measured prior to the cryocompression device being applied; every 5 minutes during the 30 minute test; and every 5 minutes after the test until skin temperature >15℃. | Device | Condition A, Condition B, Condition C, Condition D |
Primary outcome
Skin Temperature
Time frame: up to 14 days
Skin temperature will be measured using a thermocouple positioned 20 mm distal to the patella. This sensor will be attached prior to the cryocompression device being applied, and will remain in place until the testing session is complete and skin temperature is >15℃. (The therapeutic skin temperature range for cryotherapy is thought to be 10-15℃). Temperature will be measured prior to the cryocompression device being applied; every 5 minutes during the test; and every 5 minutes after a test until the skin temperature reaches >15℃.
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 19 May 2022.
- Background: PubMed 12776983Wilke B, Weiner RD. Postoperative cryotherapy: risks versus benefits of continuous-flow cryotherapy units. Clin Podiatr Med Surg. 2003 Apr;20(2):307-22. doi: 10.1016/S0891-8422(03)00009-0.
- Background: PubMed 14754753Bleakley C, McDonough S, MacAuley D. The use of ice in the treatment of acute soft-tissue injury: a systematic review of randomized controlled trials. Am J Sports Med. 2004 Jan-Feb;32(1):251-61. doi: 10.1177/0363546503260757.
- BackgroundSelfe J, Hardaker N, Whittaker J and Hayes C. An investigation into the effect on skin surface temperature of three cryotherapy modalities. Thermology International. 2009; 19(4): 121-126.
- Background: PubMed 21332855Fang L, Hung CH, Wu SL, Fang SH, Stocker J. The effects of cryotherapy in relieving postarthroscopy pain. J Clin Nurs. 2012 Mar;21(5-6):636-43. doi: 10.1111/j.1365-2702.2010.03531.x. Epub 2011 Feb 20.
- Background: PubMed 22928433Waterman B, Walker JJ, Swaims C, Shortt M, Todd MS, Machen SM, Owens BD. The efficacy of combined cryotherapy and compression compared with cryotherapy alone following anterior cruciate ligament reconstruction. J Knee Surg. 2012 May;25(2):155-60. doi: 10.1055/s-0031-1299650.
- Individual participant dataSharing planned: No. No individual data will be shared outside of the researchers directly involved in the data collection itself.
Related trials for Temperature Change, Body
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
Recruiting
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
Pediatric Oncology Patients With Risk for Infections
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
Recruiting
Effect of Buzzy and Virtual Reality on Children Undergoing Venous Procedures
Fever, Children
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.
James Faulkner, PhD principal investigator
University of Winchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryocompression in people with Temperature Change, Body, run by University of Winchester at 1 site in United Kingdom.
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 9 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 19 May 2022. 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 United Kingdom. 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?
Skin Temperature (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05136482, which also lists 5 linked publications.
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 19 May 2022.